1. A MULTICENTERED, DOUBLE BLIND STUDY ON EFFICACY OF FLAX SEEDS
SUPPLEMENTATION IN IMPROVING GLYCEMIC CONTROL ON DIABETIC
INDIVIDUALS
NIAID PROTOCOL NUMBER
SPONSORED BY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
OTHER IDENTIFICATION NUMBERS
PRINCIPAL INVESTIGATOR
DRAFT OR VERSION NUMBER
15.10.2014
MEDICAL MONITOR

2. Statement of compliance:
The study will be conducted in accordance with the design and specific
provisions of this IRB approved protocol, in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and that are
consistent with GCP and the applicable regulatory requirements. The principal
investigator (PI) will assure that no deviation from, or changes to the protocol
will take place without prior agreement from the sponsor and documented
approval from the IRB, except where necessary to eliminate an immediate
hazards to the trial participants. The PI will promptly report to the IRB and the
sponsor any changes in research activity and all unanticipated problems
involving risk to human subjects or others.
Sponsor: AIIMS, New Delhi
Information provided by: Endocrinology department, AIIMS, Newdelhi
Purpose:
This project is a clinical intervention trial that will determine the role of
functional food, flax seed on control of blood glucose levels in diabetes.
People with diabetes have raised glucose concentration in the blood and
alteration in carbohydrate, protein, and fat metabolism. This can be due to
failure in the formation of insulin liberation or action. Type II diabetes is non
insulin dependent form and develops slowly and more stable. Insulin may be
produced by pancreas but action is impaired. Long term complications include
heart disease, diabetic nephropathy, neuropathy and infections.
Consequently clinicians are recognizing that glucose can be controlled
through exercise, diet and medication as standard treatment for diabetes. A
possible treatment that could be added to the standard treatment is intake of flax
seeds.
Background:
Few studies have looked at the effect of flax seeds on intake in obesity and
diabetes. Therefore, more research is needed to determine if flax seed is an
effective means of controlling glucose levels in people with diabetes.
This study will help determine whether or not eating modest amount of flax
seeds everyday will decrease the blood glucose levels.
Study centre: Approximately 10 study centres
Study period: Planned enrollment duration: 2 years
Study population: Diabetes patients within 5 years of diagnosis, Age 50 to 65
years, both gender , but not healthy volunteers.
Study type: Interventional.
Study design: Multicentred, double blind, placebo controlled.

3. No of participants: Atleast 100 randomised participants from approximately 10
study sites in india
Study start date: October 2014
Study end date: October 2016
Arms:
Assigned Interventions
Placebo Comparator: placebo group
3 g of powdered gelatin encapsulated
in opaque capsules.
Dietary Supplement: Placebo
6 capsules per day, thirty minutes
before lunch and dinner, eating 3
capsules (3 g) at a time.
Other Name: Control group
Experimental: Flaxseed oil group
Oil extracted from flax seed by
pressing the cold and encapsulated,
providing 3g per day containing 1.75
g of alpha linolenic acid.
Dietary Supplement: Flaxseed Oil
6 capsules per day, thirty minutes
before lunch and dinner, eating 3
capsules (3 g) at a time.
Other Name: Linseed Oil
Primary objective:
The primary objective of the study is to determine if there is clinical decline in
blood glucose levels. Active treatment will be compared to placebo control
against flax seed supplementation and usual medical care.
Secondary objective:
The secondary objective is to improve the quality of life and minimize the
complications of diabetes like hypertension, nephropathy, and heart disease.
Primary outcome measures:
Fasting glucose: Time frame: beginning and end of each 12 week intervention.
Secondary outcome measure:
Fasting lipid profile: Beginning and end of each 12 week intervention
Urea and creatinine: Beginning and end of each 12 week intervention
Blood pressure: Beginning and end of each 12 week intervention
Main inclusion criteria:
1. No unresolved health conditions
2. Non smoking status
3. No regular history of flax seed oil/flaxseed supplementation or fish oil.
4. Willingness to follow study protocol, scheduling and testing location
5. Participant is willing to give informed consent and commit to long term
followup.

4. Main exclusion criteria:
1. Smoker
2. Regular history of flaxseed intake
3. Unwillingness to follow study protocol, scheduling, testing locations
4. Men/Women greater than 65 years or less than 50 years
5. Participation in other drug studies or receipt of other investigation drugs
within 30 days prior to baseline.
Visit schedule:
V1 – screening of eligibility
V2 – Beginning and end of each 12 week
Contacts & Locations:
Choosing to participate in a study is an important personal decision. Talk with
your doctor and family members or friends about deciding to join a study. To
learn more about this study, you or your doctor may contact the study research
staff using the Contacts provided below.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698112
Locations:
All India Institute of medical sciences, AIIMS, New Delhi
Endocrinology department, AIIMS, Newdelhi
Investigators:
Principal Investigators: Andrea Mishra, Ph.d., All India Institute of medical
sciences