Home » Trials » SLCTR/2025/007
Impact of Sustained Vegetarian Diet on Weight Maintenance, Nutrient Selection and Food Choice – An Interventional Study in the Western Province, Sri Lanka
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SLCTR Registration Number
SLCTR/2025/007
Date of Registration
The date of last modification
Feb 21, 2025
Scientific Title of Trial
Impact of Sustained Vegetarian Diet on Weight Maintenance, Nutrient Selection and Food Choice – An Interventional Study in the Western Province, Sri Lanka
Public Title of Trial
Evaluating the Impact of a Vegetarian versus Omnivorous Diet on Weight Maintenance, Nutrient Intake, and Food Choices in Adults Living in the Western Province of Sri Lanka: A Randomized Study
Disease or Health Condition(s) Studied
Nutrition
Scientific Acronym
VeNus Study (Vegetarian Diet, Nutrient Selection, and Food Choices in Sri Lanka)
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1317-8932
Any other number(s) assigned to the trial and issuing authority
FMS/USJ/ERC: 58/24
What is the research question being addressed?
How does adhering to a vegetarian diet for at least three months influence weight maintenance, nutrient intake, and food choices among adults in the Western Province of Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Participants of the proposed study will be omnivores residing in the Western Province of Sri Lanka, recruited through an open call and screened for eligibility.
Recruitment and randomization: A predetermined number of participants (quota) will be collected from the three districts (i.e., Colombo, Gampaha, Kalutara) of the Western Province, based on stratified sampling technique. Eligible participants will be randomly assigned using a computer-generated randomization process into one of two groups:
Intervention
• Intervention Group: Participants will transition to a vegetarian diet for a 3-month period, excluding all meat but allowing eggs. • Control Group: Participants will continue their usual omnivorous diet throughout the intervention period.
Anthropometric measures, including BMI, hip-to-waist ratio, and waist circumference, will be recorded for all participants at baseline (pre-intervention) and at the end of the intervention (post-intervention). Eating behavior measures, such as food choice, intake, and preference for vegetables, will also be assessed at the same intervals. Participants in both groups will be monitored through food recalls to ensure adherence to the vegetarian diet, and both groups will maintain food diaries during the study period. These measures will help evaluate the impact of the dietary intervention on weight maintenance and food choice behavior.
No drugs or forced diets will be used in this trial; participants will consume food of their own choice and availability. A nutritionist will oversee their nutritional intake and provide guidance during monthly meetup sessions.
Inclusion criteria
Exclusion criteria
Individuals who have; 1.Diagnosed with medical issues which can cause unintentional weight gain or affect overall dietary behaviour and health. 2. Unhealthy obsession like frequent smoking which could affect the body weight, nutrient selection. 3. Pregnant or breast-feeding women. 3. Cultural, religious, or financial restrictions to adopt to a vegetarian diet.
Primary outcome(s)
|
1.
Body composition measures (i.e., BMI, Hip-to-Waist Ratio, Waist-to-Height Ratio, body fat %) between the control and the interventional group Method - from anthropometric measures |
[ Phase 1 (baseline - Week 0) and Phase 3 (after 3 months) ] |
|
2.
Macronutrient (Dietary fibre, fat, carbohydrates, proteins) and micronutrient (e.g., Calcium, vitamin D, protein, magnesium, and vitamin K) intake between the control and the interventional group Method - from food frequency questionnaire data |
[ Phase 1 (baseline - Week 0) and Phase 3 (after 3 months) ] |
|
3.
Food choice and intake between the control and the interventional group Method - from food frequency questionnaire data |
[ Phase 1 (baseline - Week 0) and Phase 3 (after 3 months) ] |
Secondary outcome(s)
|
1.
Physical activity Method - IPAQ Physical activity questionnaire |
[ Phase 1 (baseline - Week 0), Phase 2 (during intervention), and Phase 3 (after 3 months) ] |
Target number/sample size
40 (20 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-03-01
Anticipated end date
2025-06-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
N/A
Status
Approved
Date of Approval
2024-11-28
Approval number
FMS/USJ/ERC: 58/24
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardanepura. |
| Institutional Address: | Gangodawila, Nugegoda, Sri Lanka |
| Telephone: | +94 11 2758000 Ext 4075 |
| Email: | erc.fms@sjp.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Sashie Abeywickrema
Senior Lecturer
Department of Food Science and Technology, Faculty of Applied Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
(+94)112758468
0712677440
sashie.abey@sjp.ac.lk
https://science.sjp.ac.lk/fst/dr-sashie-abeywickrema/
Contact Person for Public Queries
Piumi Methma
Student Researcher
Department of Food Science and Technology, Faculty of Applied Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
(+94)112758468
0741895990
as2020719@sci.sjp.ac.lk
Primary study sponsor/organization
Faculty of Applied Sciences, University of Sri Jayewardenepura,
Gangodawila, Nugegoda, Sri Lanka
Tel: 0112 802 914
http://science.sjp.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant-level data (IPD) from this study will be made available after the publication of the study results. Data will be anonymized and shared through a secure platform upon request, with access granted to researchers for non-commercial, academic purposes only. A Data Use Agreement (DUA) will be required, outlining terms for data handling, privacy, and publication. The data will include demographic, health, and dietary information, while ensuring confidentiality and compliance with ethical guidelines. For data access requests, please contact the Principal Investigator at sashie.abey@sjp.ac.lk.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
