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CTRI Number  CTRI/2023/03/050421 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Food]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of almond consumption on gut health and glycemic control in adults with prediabetes 
Scientific Title of Study   Effect of almond supplementation on gut health and glycemic control in adults with prediabetes in rural settings of Karnataka, India  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
U1111-1287-9724  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Vaidya 
Designation  Assistant Professor 
Affiliation  Ramaiah International Centre for Public Health Innovations 
Address  Ramaiah International Centre for Public Health Innovations, Ramaiah Medical College Building - 1, Basement, MSR Nagar, Mathikere, Bangalore, Karnataka
Ramaiah International Centre for Public Health Innovations, Ramaiah Medical College Building - 1, Basement, MSR Nagar, Mathikere, Bangalore, Karnataka
Bangalore
KARNATAKA
560054
India 
Phone  07227983849  
Fax    
Email  ruchi.vaidya@ramaiahgroup.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Vaidya 
Designation  Assistant Professor 
Affiliation  Ramaiah International Centre for Public Health Innovations 
Address  Ramaiah International Centre for Public Health Innovations, Ramaiah Medical College Building - 1, Basement, MSR Nagar, Mathikere, Bangalore, Karnataka
Ramaiah International Centre for Public Health Innovations, Ramaiah Medical College Building - 1, Basement, MSR Nagar, Mathikere, Bangalore, Karnataka
Bangalore
KARNATAKA
560054
India 
Phone  07227983849  
Fax    
Email  ruchi.vaidya@ramaiahgroup.org  
 
Details of Contact Person
Public Query  
Name  Dr Pramila Kalra 
Designation  Professor and Head  
Affiliation  M S. Ramaiah Medical College and Memorial Hospital 
Address  Department of Endocrinology and Metabolism. M S Ramaiah Medical College and Memorial Hospital, Bangalore
Bangalore
Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  kalra.pramila@gmail.com  
 
Source of Monetary or Material Support  
Almond Board of California for financial report 
Ramaiah International Centre for Public Health Innovations , Bangalore for infrastructure support 
 
Primary Sponsor  
Name  Almond Board of California 
Address  1150 Ninth Street, Suite 1500, Modesto, CA 95354 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Vaidya  Ramaiah International Centre for Public Health Innovations  Ramaiah Medical College Building - 1, Basement, MSR Nagar, Mathikere, Bangalore, Karnataka
Bangalore
KARNATAKA 		 07227983849

ruchi.vaidya@ramaiahgroup.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
MSRMC Ethics Committee  Approved 
MSRMC Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pre diabetes adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Almonds  - Food intervention: Almonds - Amount to be consumed per day: 56grams - Duration: 16 weeks - Route of administration: oral 
Comparator Agent  Traditional cereal pulse based snacks  - Food intervention: isocaloric cereal pulse based snacks - Amount to be consumed per day: isocaloric to intervention - Duration: 16 weeks - Route of administration: oral 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age 20 years to 50 years, Both male and female, BMI 18.9 to 25 kg/m2, no nut allergies, willing to participate in the study, fasting blood glucose levels between 100 to 125 mg/dl, post-prandial blood glucose levels between 140 to 199 mg/dl, HbA1c level between 5.7 to 6.4, no comorbidities such as thyroid, diabetes, chronic kidney disease, alcoholic liver disease, or any known case of cardiovascular disease, not taking medications (steroids and beta-blockers, antibiotics) known to influence metabolism and appetite, not be a chronic alcohol dependent or chronic tobacco consumption 
 
ExclusionCriteria 
Details  Pregnant women and lactating mothers, not willing to participate in the study, BMI more than 25 kg/m2, nut allergies, fasting blood glucose less than 100 mg/dL and more than 125 mg/dL, random blood glucose more than 200 mg/dL, HbA1c levels less than 5.6 and more than 6.5, other comorbidities such as thyroid, diabetes, chronic kidney disease, alcoholic liver disease, or any known case of cardiovascular disease, on medications (steroids and beta-blockers, antibiotics) known to influence metabolism and appetite, chronic illness, chronic alcohol dependent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
HbA1c  16th week 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Glycemic control (FBS, PPBS)
Fasting Insulin, HOMA IR
 		 baseline, 8th week, 16th week
 
Lipid profile (TC, TG, HDL, non-HDL, LDL, VLDL)  baseline, 8th week, 16th week 
Blood pressure (SBP, DBP),   baseline, 8th week, 16th week 
Inflammatory markers (IL-6, hs CRP), S creatinine, S urea  baseline, 8th week, 16th week 
Thyroid levels (TSH, T4)
Liver function markers (SGPT, SGOT, GGT, s. bilirubin and s. protein
albumin)
 		 baseline, 8th week, 16th week 
Anthropometric parameters ( body weight, body height, BMI, waist
circumference, neck circumference and hip circumference )
Dietary assessment (24 hr dietary recall)
Physical activity assessment (PAL levels) 		 baseline, 8th week, 16th week 
Gut microbiota composition (Lactobacilli spp & Bifidobacteria spp.)
Short chain fatty acid composition (SCFA) 		 baseline, 8th week, 16th week 
GLP-1  Baseline,Endline 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
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)   02/04/2023 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ruchi.vaidya22@gmail.com].

  6. For how long will this data be available start date provided 03-02-2024 and end date provided 03-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

A cluster parallel randomized control trial is designed to study the effect of almond consumption on glycemic control and gut health among the adults with prediabetes in the rural settings of Karnataka, India. Screening camps will be organized at the Chikbalapur, Kolar and Rural Bangalore taluks of Karnataka. After obtaining informed consent, a total of 178 adults aged 20-50 years with prediabetes will be enrolled from the 10 villages (considering each village as 1 unit) of these taluks. The villages will be randomly divided into control and intervention groups. The intervention group will be provided 56g of almonds as a midmorning snack whereas the counter group will be given a traditional isocaloric cereal-pulse based snack for a period of 16 weeks. The anthropometric measurements, metabolic control indicators (blood glucose levels, HbA1c, fasting insulin levels, lipid profile, liver function tests, serum creatinine, serum urea, TSH, T4 and inflammatory markers), and gut health indicators (fecal short chain fatty acids (SCFA) levels and beneficial microbiota counts) will be measured at 0,8 and 16 weeks of all the study participants. The trend of glucagon-like peptide (GLP-1) levels at 0, 10, and 30 minutes will be measured in a subgroup of 60 participants after consuming the midmorning snacks during 0 and 16th week of the intervention period. Side effects will be unlikely, but if any severe side effects due to the intervention are detected, participants will be withdrawn from the study. The study will be registered in India’s clinical trial registry. The proposed study is the first of its kind of long-term cluster randomized control trial in rural settings of India to evaluate the effect of almonds on glycemic control and gut health among adults with prediabetes. 

 
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