| CTRI Number |
CTRI/2020/11/029340 [Registered on: 24/11/2020] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nuts] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pistachio and blood glucose response |
|
Scientific Title of Study
|
Effect of pistachios on dietary glycemic load,cardiometabolic risk factors, and the gut microbome among Asian Indian adults with pre-diabetes-A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudha Vasudevan |
| Designation |
Senior scientist and head |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Foods Nutrition and Dietetics Research
Madras Diabetes Research Foundation
No.6b Conran Smith Road
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudha Vasudevan |
| Designation |
Senior scientist and head |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Foods Nutrition and Dietetics Research
Madras Diabetes Research Foundation
No.6b Conran Smith Road
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudha Vasudevan |
| Designation |
Senior scientist and head |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Foods Nutrition and Dietetics Research
Madras Diabetes Research Foundation
No.6b Conran Smith Road,
Gopalpuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| American Pistachio Growers
9 River Park Pl E #410, Fresno, CA 93720, United States |
|
|
Primary Sponsor
|
| Name |
American Pistachio Growers |
| Address |
9 River Park Pl E #410, Fresno, CA 93720, United States |
| Type of Sponsor |
Other [non-profit trade association] |
|
|
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 |
| Mrs Sudha Vasudevan |
MADRAS DIABETES RESEARCH FOUNDATION |
Department of Foods Nutrition and Dietetics Research
Madras Diabetes Research Foundation
No.6b Conran Smith Road, Gopalpuram
Chennai
TAMIL NADU |
9840014480
s2r_7@mdrf.in |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
Adults with pre diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control arm participants will adhere to the standard Indian diet wherein the intake of any nuts will be restricted. |
| Intervention |
Pistachio |
Intervention arm participants will be provided approximately 60g of roasted pistachios daily as a part of everyday meal (30g/meal for 2 meals) adjusted for carbohydrate and fat calories in their standard Indian diet for a period of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Hypertension
Pre-diabetes (Impaired fasting glucose: fasting capillary blood glucose ≥110mg/dl and <126mg/dl and/or Impaired glucose tolerance: plasma glucose 2-hrs post after 75g glucose load ≥140mg/dl but <200mg/dl)
|
|
| ExclusionCriteria |
| Details |
Self-reported diabetes
Current daily and weekly tobacco users
History of allergy to nuts
Patients on oral steroids, metformin, on hormonal replacement therapy
History of bariatric surgery or have underwent any major surgery in last 6 months
Use of nutritional supplements
Bad dentures
Patients with cancer,
Patients on medications for psychiatric disorders,
Active weight loss (more than 3 kg in the last month)
• Pregnant/lactating women
Presence of severe liver, kidney, thyroid, or other endocrine diseases
Any condition that hinders compliance to the intervention.
Possible eating disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in 1) fasting glucose, 2) 2hour post glucose load; |
2 time points
1.Baseline-at the time of study commencement
2.End- at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in
Insulin resistance measured by HOMA-IR
Lipid profile
changes in body weight and blood pressure
Selected Pro-inflammatory and anti-inflammatory markers
Cellular glucose uptake and mRNA gene expression studies Gut microbiome in a sub sample
24 hr glycemic response using flash glucose monitoring device. |
baseline-before commencement of study
End of study-end of 3 months intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/01/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Indian
diets are high in GL mainly derived from the 3 meals, a positive study outcome would
help to provide evidence that as little as 30g of roasted pistachio in each
day’s breakfast and dinner over 12 weeks could help to reduce GL in Indian
diets. Indian diets are also deficient in MUFA with the current intake of 6.9%E
(median) providing only half of the recommended intake. Addition of 60g of
pistachio providing 11.4g of MUFA could increase the MUFA calories to 11%E. This
will support the hypothesis that replacing carbohydrates with pistachio (with good
quality of fat especially MUFA) would not only reduce the metabolic risk but also
improve the overall quality of the Asian Indian diet as pistachios are a rich
source of protein, MUFA and other phytonutrients that are currently low in Indian
diets. In addition, intake of 60g roasted pistachio per day will help to
improve the daily intake of PUFA particularly n3-PUFA, alpha linolenic acid (ALNA)
intake by about 15-17%.
This study
will give an insight on the efficacy of roasted pistachios on modulating cardiometabolic
risk and especially glucose and insulin related parameters. This will then be a
simple dietary tool for physicians, dietitians and other health care
professionals to promote and enable improved dietary adherence and a better
strategy to reduce the risk of diabetes by reducing the metabolic risk factors
for diabetes.
|