| CTRI Number |
CTRI/2024/07/070656 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of alternate day fasting and the 5:2 diet on adults with overweight and obesity. |
|
Scientific Title of Study
|
Comparison of the effectiveness of different regimens of intermittent fasting in overweight and obese adults. |
| 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 Sandeep Garg |
| Designation |
Director Professor |
| Affiliation |
ualana Azad Medical College and Associated Hospitals |
| Address |
Department of Medicine,
Maulana Azad Medical College and Associated Hospitals,
Bahadur Shah Zafar Marg,
Central
DELHI
110002
India |
| Phone |
01123239271 |
| Fax |
|
| Email |
drsandeepgargmamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Garg |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and Associated Hospitals |
| Address |
Department of Medicine,
Maulana Azad Medical College and Associated Hospitals,
Bahadur Shah Zafar Marg,
Central
DELHI
110002
India |
| Phone |
01123239271 |
| Fax |
|
| Email |
drsandeepgargmamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Goel |
| Designation |
Ph. D. Scholar |
| Affiliation |
Bhaskaracharya College of Applied Sciences, University of Delhi |
| Address |
Department of Food Technology,
Bhaskaracharya College of Applied Sciences,
(Department of Home Science,
University of Delhi)
Phase 1, Sector 2, Dwarka
South West
DELHI
110075
India |
| Phone |
01125087597 |
| Fax |
|
| Email |
shikha.phd@bcas.du.ac.in |
|
|
Source of Monetary or Material Support
|
| Infrastructural support by Lok Nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Associated Hospitals |
| Address |
Maulana Azad Medical College and Associated Hospitals,
2, Bahadur Shah Zafar Marg,
New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sandeep Garg |
Lok Nayak Hospital |
Medicine OPD and Endocrine Clinic,
New OPD Block,
LNH, New Delhi 110002
Central
DELHI |
01123239271
drsandeepgargmamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E66||Overweight and obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate Day Fasting (ADF) |
Participants to fast on alternate days, consuming only 25% of one day calorie requirement.
A routine diet on non-fasting days. |
| Comparator Agent |
Control group |
Participants would be prescribed to take a balanced diet for the whole study duration of 12 weeks, under standard of care. |
| Intervention |
The 5:2 Diet |
Participants to fast for 2 days per week consuming only 25% of one day calorie requirement.
A routine diet on non-fasting days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Body Mass Index equals or greater than 23 kilograms per square meter (as per WHO Asian BMI classification),
2. Able to give informed consent,
3. Not planning to relocate within 6 months of the study,
4. Willing to participate in this weight loss intervention. |
|
| ExclusionCriteria |
| Details |
1. Individuals suffering from disorders like Celiac disease, uncontrolled thyroid disorder, anorexia bulimia.
2. Individuals with comorbid conditions in which dietary restrictions will be detrimental like individuals with Stroke, Cardiomyopathy, Coronary artery disease, other Cardio-vascular disease, Chronic Obstructive Pulmonary Disease, Alzheimers disease, Depression.
3. Individuals who have previous weight loss surgery, moderate or severe chronic hepatorenal diseases or cardio-cerebrovascular diseases, current acute complications of diabetes, such as diabetic ketosis, hyperglycaemia and hypertonicity in the past 3 months, stress diseases such as surgery, trauma, and cardiovascular and cerebrovascular events, and mental disorders requiring antipsychotic drugs.
4. Women who are lactating, pregnant or planning for pregnancy.
5. Individuals undergoing some weight loss intervention or have undergone weight loss intervention within 3 months tim
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body weight, body mass index |
At Baseline 0 week
At Midline 6 weeks
At Endline 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in body fat, visceral fat, improvement in waist to hip ratio |
At Baseline 0 week
At Midline 6 weeks
At Endline 12weeks |
| Lipid levels, Fasting Blood Glucose, HbA1C, HOMA IR, Fasting insulin, Ferritin, IL-6, Adiponectin, Total energy intake. Improvement in quality of life and parameters like physical, emotional and social well-being |
At Baseline 0 week
At Endline 12 weeks |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/07/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-04-2028 and end date provided 31-03-2032?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - none
|
|
Brief Summary
|
This parallel group
interventional study is designed to compare the effect of Alternate Day Fasting
(ADF) vs The 5:2 diet vs control group, on various anthropometric, biochemical,
clinical and nutritional parameters and quality of life in overweight and obese
adults in a 12-week comprehensive behavioural weight loss intervention. Hypothesis: Alternate Day Fasting
(ADF) and the 5:2 Diet prescribed to overweight and obese adults would lead to
weight loss and improvement in metabolic markers and quality of life compared
to the individuals in control group under standard care. |