|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
24 November 2021 |
|
Main ID: |
CTRI/2018/02/011927 |
|
Date of registration:
|
15-02-2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Almond Consumption on Blood Glucose Regulation in prediabetics
|
|
Scientific title:
|
Effect of Almond Consumption on Blood Glucose Regulation and Cardio-Metabolic Risk Factors in Adolescents and Young Adults (16-25years) with Prediabetes |
|
Date of first enrolment:
|
01-09-2017 |
|
Target sample size:
|
240 |
|
Recruitment status: |
Closed to Recruitment of Participants |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22407 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Jagmeet Madan
|
|
Address:
|
Dept of Food and Nutrition
Sir Vithaldas Thackersey College of Home Science (Autonomous)
SNDT Womens University,Mumbai
400049
Mumbai, MAHARASHTRA
India |
|
Telephone:
|
|
|
Email:
|
dr.jagmeetmadan@gmail.com |
|
Affiliation:
|
SNDT Womens University,Mumbai |
|
|
Name:
|
Dr Jagmeet Madan
|
|
Address:
|
Dept of Food and Nutrition
Sir Vithaldas Thackersey College of Home Science (Autonomous)
SNDT Womens University,Mumbai
400049
Mumbai, MAHARASHTRA
India |
|
Telephone:
|
|
|
Email:
|
dr.jagmeetmadan@gmail.com |
|
Affiliation:
|
SNDT Womens University,Mumbai |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Pre-diabetics
BMI ( Asian Cutoffs) ranging from 18.5 รข?? 30
Exclusion criteria: Chronic Energy deficiency with BMI less than 16.5
Any chronic disease eg allergies, eczema and asthma, renal disease, endocrinological problems, chronic infections, those who are on medications like steroids, diabetics
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
|
|
Intervention(s)
|
Intervention1: Almonds: 20 percent of daily calorie intake of almonds given
Control Intervention1: Healthy snack: Iso-caloric healthy snack which would have similar calories as the intervention ( almonds)
|
|
Primary Outcome(s)
|
|
Improvement in pre-diabetic state- Improvement in fasting blood glucose or 2 hourly blood glucose level.Timepoint: 3 months
|
|
Secondary Outcome(s)
|
1) Insulin sensitization
2) Improvement in Lipid profile
3) Reduction in oxidized LDL
4) Reduction in inflammatory markers
5) Improvement in Quality of Life
Timepoint: 3 months
|
|
Source(s) of Monetary Support
|
|
SNDT Womens University
1, Nathibai Thackersey Road, Mumbai, Maharashtra 400020
|
|
Ethics review
|
Status: Approved
Approval date: 12/08/2017
Contact:
IntersystemBiomedica Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|