NMR, a nutraceutical-focused contract research organization, has launched a new product called Safety Monographs. The monographs provide a highly detailed summary of a proprietary product or ingredient, including a review of active constituents, safety recommendations based on scientific evidence, proposed mechanisms of action, recommended research, and the latest clinical data and trials. Companies can order 20 copies of the monograph along with figures and tables, as well as a PowerPoint presentation summarizing the findings. NMR invites companies to request a quote to have a Safety Monograph developed on their products or ingredients.
1) Evidence from studies supports the cardiovascular benefits of omega-3 fatty acids, including lowering triglycerides and inflammation, preventing arrhythmias, and decreasing platelet aggregation.
2) The American Heart Association recommends eating fatty fish twice a week to help maintain cardiovascular health based on the strength of evidence for omega-3 fatty acids.
3) Specific omega-3 fatty acids like EPA and DHA have benefits such as decreasing risk of arrhythmia and thrombosis and stabilizing plaques, while ALA intake is associated with decreased cardiovascular disease risk.
In recognition of foot health month, the status of tea tree oil as an antimicrobial agent is reviewed. Tea tree oil shows great promise as an antifungal and antibacterial product. This includes topical infections of foot and toe nails.
The document summarizes the identification and isolation of harmaline, a beta-carboline alkaloid, from the leaves of Passiflora foetida. The leaves were extracted using hydroalcohol and the extract was subjected to column chromatography to isolate harmaline. Harmaline was identified using UV, H-1 NMR, and mass spectroscopy. The isolation method provides an effective and economic means to obtain harmaline from P. foetida, as synthetic approaches are costly and time-consuming.
A pooled analysis of 25 clinical trials found that consuming an average of 67 grams of nuts per day for at least 3 weeks resulted in decreases in total cholesterol levels by 5.1%, LDL cholesterol by 7.4%, the LDL/HDL ratio by 8.3%, and the total cholesterol/HDL ratio by 5.6%. Triglyceride levels decreased by 10.2% in individuals with triglyceride levels over 150 mg/dL. The study concluded that incorporating nuts into a daily diet can improve blood lipid levels, especially in individuals following a healthy diet.
Clostridium difficile is a bacterium that causes intestinal infections and can be life-threatening. It is becoming more common in hospitals and long-term care facilities. Standard treatments include antibiotics, but some strains are resistant. Probiotics may help prevent and treat C. difficile infections by replacing normal gut bacteria. Preliminary clinical trials found probiotic supplements containing Lactobacillus, Bifidobacterium, and Saccharomyces yeast reduced the risk of C. difficile infections in hospitals and recurrences after treatment. However, more research is still needed to establish effective probiotic treatment protocols.
The document discusses the need for the FDA to provide clear guidance for structure/function claims for conventional foods and beverages. It notes that while guidance exists for dietary supplements, foods are a more essential part of nutrition. It recommends that the FDA define what constitutes a "misleading" claim, clarify acceptable language for claims, and provide guidance on the types of scientific evidence required to substantiate different kinds of claims, such as those based on single nutrients, whole foods, or ingredients. Specific recommendations are given around defining claim language, types of required human studies, and standards of evidence. The document argues this guidance is necessary to help companies comply with regulations and provide consumers with valid claims.
NMR, a nutraceutical-focused contract research organization, has launched a new product called Safety Monographs. The monographs provide a highly detailed summary of a proprietary product or ingredient, including a review of active constituents, safety recommendations based on scientific evidence, proposed mechanisms of action, recommended research, and the latest clinical data and trials. Companies can order 20 copies of the monograph along with figures and tables, as well as a PowerPoint presentation summarizing the findings. NMR invites companies to request a quote to have a Safety Monograph developed on their products or ingredients.
1) Evidence from studies supports the cardiovascular benefits of omega-3 fatty acids, including lowering triglycerides and inflammation, preventing arrhythmias, and decreasing platelet aggregation.
2) The American Heart Association recommends eating fatty fish twice a week to help maintain cardiovascular health based on the strength of evidence for omega-3 fatty acids.
3) Specific omega-3 fatty acids like EPA and DHA have benefits such as decreasing risk of arrhythmia and thrombosis and stabilizing plaques, while ALA intake is associated with decreased cardiovascular disease risk.
In recognition of foot health month, the status of tea tree oil as an antimicrobial agent is reviewed. Tea tree oil shows great promise as an antifungal and antibacterial product. This includes topical infections of foot and toe nails.
The document summarizes the identification and isolation of harmaline, a beta-carboline alkaloid, from the leaves of Passiflora foetida. The leaves were extracted using hydroalcohol and the extract was subjected to column chromatography to isolate harmaline. Harmaline was identified using UV, H-1 NMR, and mass spectroscopy. The isolation method provides an effective and economic means to obtain harmaline from P. foetida, as synthetic approaches are costly and time-consuming.
A pooled analysis of 25 clinical trials found that consuming an average of 67 grams of nuts per day for at least 3 weeks resulted in decreases in total cholesterol levels by 5.1%, LDL cholesterol by 7.4%, the LDL/HDL ratio by 8.3%, and the total cholesterol/HDL ratio by 5.6%. Triglyceride levels decreased by 10.2% in individuals with triglyceride levels over 150 mg/dL. The study concluded that incorporating nuts into a daily diet can improve blood lipid levels, especially in individuals following a healthy diet.
Clostridium difficile is a bacterium that causes intestinal infections and can be life-threatening. It is becoming more common in hospitals and long-term care facilities. Standard treatments include antibiotics, but some strains are resistant. Probiotics may help prevent and treat C. difficile infections by replacing normal gut bacteria. Preliminary clinical trials found probiotic supplements containing Lactobacillus, Bifidobacterium, and Saccharomyces yeast reduced the risk of C. difficile infections in hospitals and recurrences after treatment. However, more research is still needed to establish effective probiotic treatment protocols.
The document discusses the need for the FDA to provide clear guidance for structure/function claims for conventional foods and beverages. It notes that while guidance exists for dietary supplements, foods are a more essential part of nutrition. It recommends that the FDA define what constitutes a "misleading" claim, clarify acceptable language for claims, and provide guidance on the types of scientific evidence required to substantiate different kinds of claims, such as those based on single nutrients, whole foods, or ingredients. Specific recommendations are given around defining claim language, types of required human studies, and standards of evidence. The document argues this guidance is necessary to help companies comply with regulations and provide consumers with valid claims.
Bilberry is a shrub related to blueberries found in parts of Europe and Asia. Its berries contain anthocyanosides, a flavonoid with antioxidant properties. Claims have been made that bilberry improves night vision and protects against cataracts and glaucoma, but evidence is mixed. While some studies found benefits, others found no effect. Further research is still needed, including studies to identify mechanisms of action and large-scale clinical trials, before health claims can be verified.
The FDA issued warning letters to 17 food companies for unauthorized health and nutrient content claims on product labels. The FDA commissioner sent a letter encouraging companies to review labels to ensure compliance. Two companies claimed "zero grams trans fat" but had high saturated fat levels, which can be misleading. The FDA will propose front-of-package labeling guidance to improve consumer nutrition information and choices. Critics argue stricter rules are needed to prevent misleading claims, including banning some types of claims.
Chocolate may have some cardiovascular health benefits due to antioxidants and flavonoids. Small studies suggest chocolate can lower blood pressure and reduce heart disease risk. However, more research is needed to confirm these effects. Chocolate also contains small amounts of nutrients but should be enjoyed in moderation due to sugar and fat content. While chocolate appears safe for humans, animals cannot metabolize theobromine in chocolate and should not eat it.
The FDA has issued draft guidance for IRBs, clinical investigators, and sponsors on conducting continuing review of multi-site clinical trials. The guidance proposes that IRBs use a centralized or cooperative review process to oversee collective data from all trial sites. IRBs would review approved research at least yearly, but determine a more frequent review schedule based on a study's risk level. The guidance also specifies that IRBs proactively obtain a study's progress updates from sponsors and provides recommendations for expedited reviews and determining continuing review dates. The FDA aims for these guidelines to better ensure safety and protection of subjects in clinical investigations across multiple sites.
1) Atopic dermatitis is a chronic inflammatory skin condition that causes dry, itchy skin and is often treated through conventional methods like antihistamines or steroids.
2) Natural approaches include identifying and avoiding environmental triggers like foods, soaps, or plants that cause flare ups, as well as moisturizing to relieve dryness and inflammation.
3) Moisturizers add water back into the skin and contain ingredients like glycerol, vitamin E, or evening primrose oil to hydrate, while avoiding scratching prevents worsening symptoms.
The document provides an outlook on the dietary supplement industry for 2010. It predicts that 1) branded ingredients with strong clinical evidence will grow as companies use them to differentiate products, 2) condition-specific supplements targeting health issues will see increased popularity among consumers seeking alternatives to medication, and 3) functional foods and beverages fortified with scientifically-backed ingredients will gain more consumer demand. It also notes that 4) education of consumers, manufacturers, retailers, and medical professionals about available clinical evidence will be important for companies to build trust and loyalty in their brands.
Moringa oleifera is a cultivated tree native to northwest India that is now grown in many tropical and subtropical areas. All parts of the tree are edible and provide important nutrients. Research is exploring Moringa oleifera's potential health benefits, including using extracts to decrease inflammation and pain, inhibit viral and fungal infections, possibly inhibit cancer cell growth, and improve cardiovascular health by reducing cholesterol and oxidative stress. However, more research is still needed before claims can be made about its effectiveness in treating diseases.
Probiotics are live microorganisms that provide health benefits when consumed. Common probiotic strains include Lactobacillus and Bifidobacteria. Probiotics have shown benefits for digestive health such as controlling diarrhea, stomach upset, and constipation. Evidence also suggests probiotics may help control urinary tract infections, candidiasis, and help replace beneficial microbes after antibiotic use. However, more research is still needed to determine the specific health benefits of different probiotic strains. Probiotics are generally considered safe but can potentially cause infections in immune compromised individuals.
The document summarizes research on the pawpaw plant and its potential use as a natural insecticide. It finds that pawpaw contains compounds called acetogenins that have pesticidal properties, especially in the small twigs. Studies showed a pawpaw extract was 100% effective in removing lice and nits from hair in shampoo. However, more research is still needed on its efficacy and safety before commercial use, though it shows promise as lice develop resistance to current treatments. The pawpaw compounds may also have anti-cancer effects but more data is required.
1) French lilac, a medicinal plant used in medieval Europe to treat diabetes symptoms, led to the development of metformin, one of the most important drugs used to treat type-2 diabetes.
2) Chemical analysis of French lilac identified guanidine, which could lower blood glucose but was toxic; related molecules like galegine and diguanides were then developed.
3) Metformin, a non-toxic derivative of guanidine, was developed in the 1950s and approved for diabetes treatment in 1979. It remains widely used today as an effective antidiabetic with few side effects.
French lilac, which was used in medieval Europe to treat diabetes and other ailments, led to the development of metformin, one of the most important drugs for treating type-2 diabetes. Analysis of French lilac in the late 1800s showed it contained guanidine, which could lower blood glucose but was toxic. This led scientists to study related molecules like galegine and diguanides. Eventually, through chemical modifications and clinical trials from the 1940s-1950s, metformin was developed from biguanides. Though its mechanism is still unknown, metformin remains widely used today as a safe and effective treatment discovered through study of an old herbal remedy.
The Value of Conducting Post-Marketing Clinical Research On Marketing Strategy Development
Nutraceutical Medical Research, LLC
By: Latesha Richards, Marketing Coordinator
The Role of Evidence in Establishing Awareness for Branded Ingredients
Author: Latesha Richards
Contributing Author: Charles Spielholz, Ph.D.
July 2009
Ginger has been shown to reduce the severity and duration of chemotherapy-induced nausea in clinical trials. Additional research suggests ginger may help treat nausea from surgery, pregnancy, and motion sickness, though more research is still needed. Laboratory research also indicates ginger may inhibit the growth of some cancer cells and protect against Alzheimer's, but these effects have not been demonstrated in human clinical trials. Ginger should not be used by those with bleeding disorders or taking blood thinners, as it can inhibit clotting. More research is still needed to determine appropriate dosages and drug interactions when using ginger as an anti-nausea supplement.
Bilberry is a shrub related to blueberries found in parts of Europe and Asia. Its berries contain anthocyanosides, a flavonoid with antioxidant properties. Claims have been made that bilberry improves night vision and protects against cataracts and glaucoma, but evidence is mixed. While some studies found benefits, others found no effect. Further research is still needed, including studies to identify mechanisms of action and large-scale clinical trials, before health claims can be verified.
The FDA issued warning letters to 17 food companies for unauthorized health and nutrient content claims on product labels. The FDA commissioner sent a letter encouraging companies to review labels to ensure compliance. Two companies claimed "zero grams trans fat" but had high saturated fat levels, which can be misleading. The FDA will propose front-of-package labeling guidance to improve consumer nutrition information and choices. Critics argue stricter rules are needed to prevent misleading claims, including banning some types of claims.
Chocolate may have some cardiovascular health benefits due to antioxidants and flavonoids. Small studies suggest chocolate can lower blood pressure and reduce heart disease risk. However, more research is needed to confirm these effects. Chocolate also contains small amounts of nutrients but should be enjoyed in moderation due to sugar and fat content. While chocolate appears safe for humans, animals cannot metabolize theobromine in chocolate and should not eat it.
The FDA has issued draft guidance for IRBs, clinical investigators, and sponsors on conducting continuing review of multi-site clinical trials. The guidance proposes that IRBs use a centralized or cooperative review process to oversee collective data from all trial sites. IRBs would review approved research at least yearly, but determine a more frequent review schedule based on a study's risk level. The guidance also specifies that IRBs proactively obtain a study's progress updates from sponsors and provides recommendations for expedited reviews and determining continuing review dates. The FDA aims for these guidelines to better ensure safety and protection of subjects in clinical investigations across multiple sites.
1) Atopic dermatitis is a chronic inflammatory skin condition that causes dry, itchy skin and is often treated through conventional methods like antihistamines or steroids.
2) Natural approaches include identifying and avoiding environmental triggers like foods, soaps, or plants that cause flare ups, as well as moisturizing to relieve dryness and inflammation.
3) Moisturizers add water back into the skin and contain ingredients like glycerol, vitamin E, or evening primrose oil to hydrate, while avoiding scratching prevents worsening symptoms.
The document provides an outlook on the dietary supplement industry for 2010. It predicts that 1) branded ingredients with strong clinical evidence will grow as companies use them to differentiate products, 2) condition-specific supplements targeting health issues will see increased popularity among consumers seeking alternatives to medication, and 3) functional foods and beverages fortified with scientifically-backed ingredients will gain more consumer demand. It also notes that 4) education of consumers, manufacturers, retailers, and medical professionals about available clinical evidence will be important for companies to build trust and loyalty in their brands.
Moringa oleifera is a cultivated tree native to northwest India that is now grown in many tropical and subtropical areas. All parts of the tree are edible and provide important nutrients. Research is exploring Moringa oleifera's potential health benefits, including using extracts to decrease inflammation and pain, inhibit viral and fungal infections, possibly inhibit cancer cell growth, and improve cardiovascular health by reducing cholesterol and oxidative stress. However, more research is still needed before claims can be made about its effectiveness in treating diseases.
Probiotics are live microorganisms that provide health benefits when consumed. Common probiotic strains include Lactobacillus and Bifidobacteria. Probiotics have shown benefits for digestive health such as controlling diarrhea, stomach upset, and constipation. Evidence also suggests probiotics may help control urinary tract infections, candidiasis, and help replace beneficial microbes after antibiotic use. However, more research is still needed to determine the specific health benefits of different probiotic strains. Probiotics are generally considered safe but can potentially cause infections in immune compromised individuals.
The document summarizes research on the pawpaw plant and its potential use as a natural insecticide. It finds that pawpaw contains compounds called acetogenins that have pesticidal properties, especially in the small twigs. Studies showed a pawpaw extract was 100% effective in removing lice and nits from hair in shampoo. However, more research is still needed on its efficacy and safety before commercial use, though it shows promise as lice develop resistance to current treatments. The pawpaw compounds may also have anti-cancer effects but more data is required.
1) French lilac, a medicinal plant used in medieval Europe to treat diabetes symptoms, led to the development of metformin, one of the most important drugs used to treat type-2 diabetes.
2) Chemical analysis of French lilac identified guanidine, which could lower blood glucose but was toxic; related molecules like galegine and diguanides were then developed.
3) Metformin, a non-toxic derivative of guanidine, was developed in the 1950s and approved for diabetes treatment in 1979. It remains widely used today as an effective antidiabetic with few side effects.
French lilac, which was used in medieval Europe to treat diabetes and other ailments, led to the development of metformin, one of the most important drugs for treating type-2 diabetes. Analysis of French lilac in the late 1800s showed it contained guanidine, which could lower blood glucose but was toxic. This led scientists to study related molecules like galegine and diguanides. Eventually, through chemical modifications and clinical trials from the 1940s-1950s, metformin was developed from biguanides. Though its mechanism is still unknown, metformin remains widely used today as a safe and effective treatment discovered through study of an old herbal remedy.
The Value of Conducting Post-Marketing Clinical Research On Marketing Strategy Development
Nutraceutical Medical Research, LLC
By: Latesha Richards, Marketing Coordinator
The Role of Evidence in Establishing Awareness for Branded Ingredients
Author: Latesha Richards
Contributing Author: Charles Spielholz, Ph.D.
July 2009
Ginger has been shown to reduce the severity and duration of chemotherapy-induced nausea in clinical trials. Additional research suggests ginger may help treat nausea from surgery, pregnancy, and motion sickness, though more research is still needed. Laboratory research also indicates ginger may inhibit the growth of some cancer cells and protect against Alzheimer's, but these effects have not been demonstrated in human clinical trials. Ginger should not be used by those with bleeding disorders or taking blood thinners, as it can inhibit clotting. More research is still needed to determine appropriate dosages and drug interactions when using ginger as an anti-nausea supplement.
1. NMR News: Volume 2, Issue 7, October 2009
A Look at Sports Nutrition Supplements: Their
Ingredients & Evidence
By: Charles Spielholz, Ph.D.
October 2009
There is a wide range of products on the market mild stimulant of known mechanism, found in coffee
known as sports supplements. The purpose of a sports and tea. Sugar is the most common molecule burned
supplement is to help the user be more energetic and by aerobic cells for energy production.
more muscular. Such products may also claim to aid
in the loss of fat and to improve recovery after Glucuronolactone, a metabolite of the sugar glucose,
strenuous exertion. In addition, some products may is included in some energy drinks because some
also claim to improve performance, although preliminary clinical studies indicate that it may
performance enhancing substances are not legal in improve high intensity endurance. However, a clear
professional sports. mechanism, of action for glucuronolactone's
proposed properties has not yet been established. In
In order to accomplish the purposes of a sports addition, few clinical trials have been done using
supplement, manufacturers use specific ingredients glucuronolactone alone. Creatine is included in some
that are supposed to have the desired effects on the sports supplements for reasons similar to that of
body. The ingredients used by manufacturers are glucuronolactone.
quite numerous and varied. No attempt will be made
to cover this wide variety in this short report. Finally, taurine has been shown again in preliminary
However, this report will discuss some of the rational clinical studies, to play a role in changes in the
behind the design of sports supplements and will be uptake of glucose. However, additional studies are
the basis for beginning a discussion on these required before regulatory agencies will allow
products. manufacturers of sports supplements to make claims
that taurine enhances energy in humans.
For providing energy, sports supplements can contain
ingredients such as caffeine, glucuronolactone, tea Energy supplements usually contain a variety of
extracts, sugar, taurine, and/or creatine. Caffeine is a ingredients to support the building of muscle. Such
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2. NMR News: Volume 2, Issue 7, October 2009
ingredients include protein (sometimes in the form of without the advice and supervision of a physician.
whey or similar substances) and amino acids. Amino Hormone and pro-hormone supplements are
acid composition of sports supplements include both dangerous to use by healthy individuals. Hormone
the essential amino acids (those required in the and pro-hormone substances should only be used by
human diet because humans can not synthesize them individuals who have a specific indication, identified
on their own) as well as the non-essential amino by a competent physician. For example,
acids. Although healthy people are able to synthesize Dehydroepiandrosterone (DHEA), which is a
their own non-essential amino acids, these amino precursor hormone to testosterone and is found
acids are added to sports supplements in order to naturally in humans, is purported to increase muscle
boost reserves when demand is high during strenuous mass and decrease fat in humans. Not only is the
exertion. evidence for these effects thin, but DHEA is known
to cause an elevation of blood pressure and to have
In addition to amino acids and protein, sports dangerous interactions with prescription drugs.
supplements can contain vitamins, minerals, fatty
acids, electrolytes and water. All of these substances Currently, sports supplements are a mixed bag. Some
can be depleted during exercise or related exertion. sports supplements which replace electrolytes, water
Although ingredients such as vitamins and minerals or provide a little extra protein or sugar are safe and
can be obtained from a vitamin supplement, it is may be useful to people who need a quick way to
convenient to have everything that is needed in one replenish low reserves of these important molecules.
source. Such an approach makes it easier to However sports supplements which make claims that
administer and keep tract of what an individual is have not been vigorously proven or contain
using. substances, whose safety has not been clearly shown,
should be used with caution if at all. Such substances
Hormones, or pro-hormones, can also be part of the are only in the early stages of clinical testing;
make up of a sports supplement. Such hormones or additional research is needed to show that the
pro-hormones are generally testosterone or ingredients are indeed effective. As with any
testosterone precursors or molecules with functions supplement, sports supplements should not be used
similar to testosterone. Such ingredients are banned by diabetics, those taking monoamine oxidase
by professional sports organizations worldwide. In (MAO) inhibitors, or who have heart, circulatory or
addition, such supplements should never be taken respiratory issues or who have cancer.
2