| CTRI Number |
CTRI/2023/09/057479 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
07/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Restiant malto dextrin] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Determination of glycemic index of dietary fibre enriched meal choices-aloo paratha and Idly |
|
Scientific Title of Study
|
Evaluation of Glycemic Index and impact on satiety of resistant malto dextrin enriched meal choices(aloo paratha and Idly)-A randomized cross over study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Diabetology, Madras Diabetes Research Foundation.
6B Conron Smith Road,Gopalapuram
Chennai 600086
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Diabetology, Madras Diabetes Research Foundation.
6B Conron Smith Road, Gopalapuram
Chennai 600086
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudha Vasudevan |
| Designation |
Senior Scientist and Head of Department of Foods, Nutrition & Dietetics Research |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
6B Conron Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Dr. Reddys Laboratories Ltd
7-1-27, Ameerpet
Hyderabad 500016, India |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No 6B Conransmith Road, Gopalapuram
Chennai 600086 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sudha Vasudevan |
Madras Diabetes Research Foundation |
Department of Foods Nutrition Dietetics Research
6B Conron Smith Road
Gopalapuram
Chennai
TAMIL NADU |
9840014480
s2r_7@mdrf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants with normal body mass index |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference food |
Glucose providing 25 or 50g available carbohydrates in 125/250 ml water will be given as reference food on 3 separate occasions. |
| Intervention |
Test food- Dietary fibre enriched aloo paratha |
Approximately 10g of dietary fibre enriched aloo paratha providing 25 or 50g available carbohydrates along with 125/250 ml water will be given as one of the test food once once on a separate occasions. |
| Intervention |
Test Food- Dietary fibre enriched idly |
Approximately 10g dietary fibre enriched Idly providing 25 or 50g available carbohydrates along with 125/250 ml water will be given as one of the test food once on a separate occasions. |
| Intervention |
Test Food- Idly |
Idly providing 25 or 50g available carbohydrates along with 125/250 ml water will be given as one of the test food once on a separate occasions. |
| Intervention |
Test food-Aloo paratha |
Aloo paratha providing 25 or 50g available carbohydrates along with 125/250 ml water will be given as one of the test food once on a separate occasions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
BMI greater than 18.5 to less than 22.9 kg/ m2 (as per WHO cut off for normal BMI)
Both male and female
Willingness to consume the test foods
no known food allergy or intolerance;
no medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins, fibre and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
|
|
| ExclusionCriteria |
| Details |
a known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within the preceding 3 months;
the presence of disease or drug(s) which influence digestion and absorption of nutrients;
the use of steroids, protease inhibitors or antipsychotics, prebiotics, and probiotics (all of which have major effects on glucose metabolism and body fat distribution) from past 30 days.
Regular use of supplements that are rich in dietary fiber or protein which influences the satiety assessment
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| glycemic index, GI category of food preparations without & with dietary fibre enrichment |
Capillary blood samples will be collected at -5,0 minutes before consumption of test and reference foods and 15,30,45,60,90,120,180,240 minutes post consumption of test and reference foods |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will also elicit, the effect of the food preparations (aloo paratha & idly) without and with dietary fibre enrichment on satiety levels assessed using gut hormones-GLP-1 and PYY levels |
Blood samples will be collected at 0 min (fasting), 60-, 120,180- & 240-minutes post consumption of intervention foods and 1 comparator glucose drink to assess selected gut hormones- GLP-1 and PYY |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research studies have shown that
lifestyle; in particular dietary aspects play an important role in preventing /
increasing the burden of the chronic diseases. Dietary habits could therefore
be modified to exert a positive impact in the prevention and treatment. It has
been suggested that the high glycemic carbohydrate foods -those foods
containing carbohydrates which elicit rapid blood glucose rise and thereby
increase the insulin demand leading to hyperinsulinemia, insulin resistance and
type 2 diabetes. Hence, there is a need to understand the blood glucose raising
potential of foods in India to be of an important tool to aid in the prevention
and or management of diabetes and its complication. Thus, evolved the concept
of ‘Glycemic Index’ (GI) which ranks the foods, based on the speed at which the
food raises the blood glucose in a scale of 0 to 100, 100 indicating high
glycemic index corresponds to oral glucose’s GI. Today, India leading the world
with the largest number of people with daibetes causing a heavy economic burden
to the country urgently needs to look at cost effective strategies to combat
this situation. A cost-effective dietary approach like estimating and
understanding the role of glycemic index of various Indian foods in the
lifestyle related diseases like diabetes is urgently needed.
Incorporation of dietary fibre in
high carbohydrate foods has been identified as a strategy to reduce the
glycemic index of foods. Intake of dietary fibre increase stomach distension,
which increases satiety and slows nutrient absorption. Further
intake of dietary fibre can favorably influence the change in gut hormone
levels that act locally and, in the brain, to affect eating behavior. Ingestion
of fibers like Fibersol®-2 increases peptide YY (PYY), which decreases appetite
by slowing gastric motility and inhibiting pancreatic secretion. It also
increases glucagon-like peptide-1 (GLP-1), which increases insulin secretion
and sensitivity and inhibits gastric acid secretion and emptying, thus
increasing satiety signals in the brain. Hence, the present study was carried
out with the following objectives. |