The document provides an overview of clinical testing for nutraceuticals and health foods, defining nutraceuticals as products that offer health benefits beyond basic nutrition. It outlines the importance of clinical trials in proving the safety, efficacy, and bioavailability of these products, detailing various phases and methodologies used in the trials. The regulatory landscape and considerations for conducting clinical research in India are also discussed.

1. CLINICAL TESTING
OF NUTRACEUTICALS
AND HEALTH FOODS
(FST:512) NUTRACEUTICALS AND HEALTH FOODS
PRESENTED BY:
NADIMINTI CHANDANA SRI SAI
22412FST012
M.SC FOOD TECHNOLOGY
1ST YEAR
DSFT – IAS, BHU
SUBMITTED TO:
DR. R. K. DUARY
DSFT – IAS, BHU

3. Clinical
trials
01
CLINICAL
TESTING
OF
NUTRACEUTICALS
AND
HEALTH
FOODS
INTRODUCTION
NUTRACEUTICALS AND
HEALTH FOODS

4. NUTRACEUTICALS
Nutraceuticals = Nutrition + Pharmaceutical coined in 1989 by Stephen DeFelice,
Foundation for Innovation in Medicine (FIM).
DEFINITION: Any substance that may be considered a food or part of a food and
provides medical or health benefits, including the prevention and treatment of
disease.
Nutraceuticals are the isolated, purified and formulated healthful products -
capsules, tinctures, or pills/tablets forms
HEALTH FOODS
DEFINITION: Foods or dietary components that may provide a health benefit
beyond basic nutrition
 Complement the regular diet, provide nourishment for the body and fight disease.
 They provide all necessary nutrients, keep us fit and add to our overall well-being.
 Healing and rejuvenating properties.
 They can be in the form of herbs, cerelas, fruits, or any other natural ingredients.
 Examples: Spirulina, Ginseng, Wheatgrass, Alfalfa, Tofu, Muesli etc.

5. CLINICAL
TRIALS
DAY
INDIAN NUTRACEUTICAL MARKET
Functional Foods and Beverages
(68%)
Dietary Supplements
(32%)
• The health and fitness consciousness of consumers, affordability resulted in rapidly growing the
popularity and growth of nutraceuticals and functional market in India.
• The Indian nutraceuticals market can be categorized broadly into dietary supplements (32%), functional
food and beverages (68%)
INDIAN NUTRACEUTICAL MARKET

6. Clinical
trials
CLINICAL
TESTING
OF
NUTRACEUTICALS
AND
HEALTH
FOODS
Nutraceuticals and health foods play a unique role in contributing to health and
protecting against illnesses outside the traditional scope of drugs by adding on to
the basic nutritional value consumed in food.
Consumers use it as an attempt to accomplish desirable therapeutic outcomes
WITH REDUCED SIDE EFFECTS.
However, with all of the aforementioned positive points, nutraceuticals
still need support of an extensive scientific study to prove
“THEIR EFFECTS WITH REDUCED SIDE EFFECTS”.
The exponential growth in the nutraceutical product and health foods requires
CLINICAL TRIALS to support safety and efficacy
Clinical trials can help sponsors to meet these requirements by providing proof of a nutraceutical’s
performance. A trial evaluates the safety, efficacy, and bioavailability of nutraceuticals – the latter of
which measures the extent and rate at which the nutraceutical is absorbed into the body.
The focus of a trial can include disease modification, disease recovery etc.

7. Clinical
trials
02
CLINICAL
TESTING
OF
NUTRACEUTICALS
AND
HEALTH
FOODS
Clinical
Research

8. CLINICAL TRIALS
• Clinical trial is a research study to develop new tests and
treatments with the aim of gauging its effects on human
health.
• The outcome of the medical intervention i.e., an
investigational product on the human volunteers is evaluated.
• A clinical trial is uniquely and thoughtfully curated for each
new product based on the needs of the stakeholders -
patients, medical practitioners and the host of the experiment.
• The trial procedure is reviewed and only when it is approved
can the trial begin.
• Thus, a clinical trial is the systematic study of majorly
nutraceutical & pharmaceutical products on human subjects in
order to discover or verify the clinical aspects and adverse
effects of the product, with the object of determining their
safety and efficacy, prior to marketing the product in India.

9. History of Clinical Research Regulation in India
Drugs and Cosmetics
Act (DCA)
1940
Schedule Y was
introduced in the DCR
1988
Indian Patents Act, creating
“process patenting regime”
1970
Introduced a four phase clinical
trial scheme and legalised the
Guidelines on Good Clinical
Practice in India
2001
CT Rules – Clinical Trial Law
ICMR Guidelines – Clinical
Research Law
Today
01
02
03
04
05

10. Human Subject and Volunteers/Patients
 The subjects (volunteers/patients) are the most important consideration
in a clinical trial.
 There are certain factors influencing the selection of volunteers/patients
for inclusion/exclusion from the trial. Pregnant women, children and
seriously ill patients are generally excluded from clinical trials, unless the
study is designed specifically to them.
 Patients having risk of an adverse reaction would also usually be
excluded.
 Clinical trials are usually carried in younger patients because certain
products are found to be more allergic in elderly patients.
 The selected subjects must be assigned to the drug treatment or
controlled group in an unbiased manner, which is usually done by
random assignment

11. Experimental Design for Clinical Trial
To avoid the selection of
volunteers/patients who are
different, in some respect
randomization is necessary. The
order of giving certain treatment
group allocated to the subjects
should be decided before the
trial starts. Each
volunteer/patient is coded with
certain code number. So that
investigator knows that which
treatment an individual is
receiving
A. Randomization
When a new drug therapy is compared with the previously
established therapy or placebo under standard conditions
it is called the controlled clinical trial. The studies are
conducted in two ways.
Firstly, one drug is given to first group and the results will
be compared with the second group.
Secondly, the one drug therapy is alternated with control
therapy or with previously established drug therapy.
The Controlled Trials are:
1. Blindness
2. Placebos
B. CONTROLLED CLINICAL TRIAL

12. In a clinical trial means that volunteers and doctor do not know
what treatment is being administered and it is done to eliminate
bias. The blindness in trial is of two types:
01 BLINDNESS:
Placebos are used in double-blind trials. They are made to match the
active treatment with respect to their size, color, taste, smell, texture
and weight etc. e.g., lactose capsule, saline injections. They are
pharmacologically inert.
02 PLACEBO
1. Single blind:
In which the patient does not know
what treatment he is receiving.
2. Double blind:
In which, neither the patient nor the doctor knows what
treatment the patient is receiving. In this technique the
drugs (either capsule or tablet or injection) are coded.
Experimental Design for Clinical Trial
B. CONTROLLED CLINICAL TRIAL

13. CLINICAL
TRIAL
LIFE
CYCLE
CLINICAL
TRIALS
DAY

14. Scientists carry out basic research in
chemistry, biochemistry, physiology,
microbiology, and pharmacology to
understand natural substances and
physiological processes associated
with the purpose of drug
development.
The data gathered during the
research and discovery phase, is
translated into disease-specific
potential new drugs.
The efficacy of a
chemical
compound is
identified at the
stage of
identification. This
is done using in
vitro screening
techniques.
A. DEVELOPMENT B. SCREENING C. IDENTIFICATION
1. Drug Discovery and Development
At the stage of screening,
chemical compounds are
screened in order to observe
their pharmacological
effects. Rapid, high efficacy
drugs screening facilitates
the determination of
whether a chemical
compound has
characteristics of a potential
drug for the disease
intended to be cured.

15. 2. Pre Clinical Research
01
This in vitro testing is followed by in
vivo testing. Both these types of
testing form part of Good Laboratory
Practices (“GLP”) along with
pharmacodynamics, pharmacokinetics
(absorption, distribution, metabolism,
and excretion), safety, toxicity, dosage,
and efficacy studies.
03
The aim should be to ensure sufficient
safety and efficiency – which is a
prerequisite for regulatory authorities to
approve the progression to the clinical
phase of a New drug.
02
The pre-clinical stage is crucial as it is
the first safety valve before in vitro
testing and helps in determining the
mechanism of action for the Lead
compounds.
04
The schedule for the pre-clinical
research in relation to clinical trial
must be decided upon by taking
into consideration – the
characteristics of the new drug,
the disease which it is intended
for, the duration and exposure of
the clinical trial subject to the
drug and the route of
administration.

16. 3.
PHASES
OF
CLINICAL
TRIAL

17. PHASE I
Human Pharmacology
01
Objective is to test the safety
and dosage of the drug, as
opposed to being undertaken
with a therapeutic perspective
02
At this preliminary stage, the
capacity of the drug to reach
the target organ or site of
action to prevent a condition
and the human body’s
tolerability towards a drug is
observed.
03
The subjects may include
about 20 to 100 people either
healthy or certain types of
patients. This phase can last
for several months
04
It should be carried out by
investigators trained in clinical
pharmacology. It may include
early measurement of drug
activity by undertaking
pharmacodynamics and
pharmacokinetic studies.

18. PHASE II
Therapeutic Exploratory
01
Objective is to check the
therapeutic efficacy, spot the
side effects, and concretise a
dosage pattern of the drug.
03
Phase II can last for
several months to 2 years,
till the dose and regimen
for phase III is finalised.
02
Up to several hundred patients
with the disease, volunteer as
trial subjects. The set of
subjects is relatively
homogenous as it is selected
through narrow criteria.
04
The subjects are divided into two sets,
one under the influence of the new drug
and the other, an old drug or an older
version. The volunteers are deprived of
the knowledge of which set they are in
so as to prevent them from developing a
bias. This process is known as blinding.

19. PHASE III: Exploratory Analysis
01
It is the large-scale version of phase II
trials. The efficacy of the drug and the
adverse reactions of the target human
population to the drug, are observed
and noted to confirm the therapeutic
benefits.
Along with this, “dosing levels” are
confirmed and a harm-benefit analysis
is conducted.
02
Several hundred to several thousand
patients who are likely to use the new
drug, are the subjects. This creates
the requisite basis for the new drug to
be used firstly, in wider population,
secondly, at different stages of the
disease, and thirdly, the safety of the
drug in combination with other drugs
may be determined.
03
Although extended exposure to the
drug may be initiated in phase II, it
is arrived at in phase III to
complete the drug prescription.
This phase goes on for about 1–4
years and may include studies in
special populations – children,
pregnant women, the elderly, and
patients with organ system
failures, etc.
04
The methodology used in this
phase is exploratory analysis and
the safety in comparison with
existing approved drugs is
examined.

20. PHASE IV: Post-marketing Surveillance
01
Phase IV must be conducted for each
new drug approved for marketing in
order to take cognizance of all rare
adverse events leading from the
utilisation and application of the drug
in a larger population. Once, the drug
has been cleared by the regulator, it is
made available to patients either with a
prescription or over-the-counter.
02
As the drug starts being used widely,
data is gathered in order to enhance
the understanding of its efficacy in
different circumstances during the
lifetime of the medicine. This propels
gradual developments.
03
Adverse reactions that occur in
fewer than 1 in 3,000 – 5,000
patients are unlikely to be detected
in Phase I – III investigational
clinical trials and may be unknown
at the time a drug is approved.
These rare adverse reactions are
more likely to be detected when
large numbers of patients are
exposed to a drug after it has been
approved and marketed.
04
Thus, this phase of the clinical
trial requires drug manufacturers
to report any adverse drug
reaction observed or reported in
the population upon receiving
approval for marketing to the
Central Licensing Authority under
the CT Rules.
01

21. 4. SAFETY TESTING IN ANIMALS
Safety tests are performed in animals to select the most suitable Lead and the most
efficient form of dosage. This set of testing includes acute, chronic, reproductive, and
developmental toxicity, carcinogenicity and other relevant test
5. APPROVALS FOR IN-HUMAN TRIALS
Drug regulators regulate the development and marketing of medical interventions for
ensuring suitability and safety of the public. Therefore, to administer drugs for the purpose
of research through clinical trials also require prior approvals and the trials scrutinised and
monitored by the drug regulators. The data collected through preclinical trial studies is
submitted to regulatory authorities for approvals to conduct first in human studies of the
drug along with Form CT-04. Specifically, these include: i. Chemical and pharmaceutical
information ii. Animal pharmacology data iii. Animal toxicology data iv. Human clinical
pharmacology data v. Regulatory Status in other countries

22. Clinical
trials
03
CLINICAL
TESTING
OF
NUTRACEUTICALS
AND
HEALTH
FOODS
LAWS AND
REGULATIONS

23. LEGAL FRAMEWORK
Mercury’s name has nothing to do with the liquid metal, since it was
named after the Roman messenger god
4
1
3
Good Clinical Laboratory Practices
5
2
Good Clinical Practice Guidelines for Clinical Research in India
issued by the CDSCO
National Ethical Guidelines for Biomedical and Health Research
involving Human Participants, 2017
New drugs and Clinical Trial Rules, 2019
Drugs and Cosmetic Act, 1940 and Drugs and Cosmetics Rules,
1945
The Indian legal framework and regulation under which clinical trials and
medical research have to be carried out mainly comprises of the following:

24. 24
REGULATORY BODIES
Indian Council Of Medical
Research
European Medicines
Agency (EMEA)
Health Canada
Medicines And Healthcare
Products Regulatory Agency
(MHRA)
EUROPEAN UNION
UNITED
KINGDOM
INDIA
CANADA
Food and Drug
Administration (FDA)
Pharmaceutical and
Medical Devices Agencies
(PMDA)
JAPAN
CLINICAL
TRIALS
DAY
5
3 6
1 4
2
USA

25. Clinical
trials
04
CLINICAL
TESTING
OF
NUTRACEUTICALS
AND
HEALTH
FOODS
CASE STUDY

27. REFERENCES
1. Ethical guidelines for biomedical research on human participants. New Delhi: 2006. Indian Council
of Medical Research.
2. Gogtay, N. J., Ravi, R., & Thatte, U. M. (2017). Regulatory requirements for clinical trials in India:
What academicians need to know. Indian journal of anaesthesia, 61(3), 192–199.
https://doi.org/10.4103/ija.IJA_143_17
3. https://www.egyankosh.ac.in/bitstream/123456789/38360/1/Unit-3.pdf
4. https://www.fda.gov/
5. https://egyankosh.ac.in/bitstream/123456789/85329/3/Unit-13.pdf
6. https://egyankosh.ac.in/bitstream/123456789/38355/1/Uint-9.pdf
7. https://clinregs.niaid.nih.gov/country/india#
8. Maiti, R., & Raghavendra, M. (2007). Clinical trials in India. Pharmacological research, 56(1), 1-10.
9. Wang, C. K. (2014). 22 Human Clinical Trial for Nutraceuticals and Functional Foods. Functional
Foods and Nutraceuticals, 325.
10. World Health Organization. (2005). Handbook for good clinical research practice (GCP): guidance
for implementation.
11. Agarwal, S. P., & Chairman, D. T. A. B. (2014). Good clinical practices for clinical research in India.

28. Clinical
trials
CLINICAL
TESTING
OF
NUTRACEUTICALS
AND
HEALTH
FOODS
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