Genetic differences and weight loss on a low-carbohydrate reduced caloric diet in Palestinian adults with overweight or obesity
| ISRCTN | ISRCTN75902461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75902461 |
| Sponsor | Al-Azhar University – Gaza |
| Funder | Al-Azhar University |
- Submission date
- 06/09/2026
- Registration date
- 21/09/2026
- Last edited
- 21/09/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity affects a large proportion of Palestinian adults. People who follow the same weight-loss diet often lose weight at very different speeds, and part of this difference may be genetic. This study looks at a small genetic variation called PLIN1 rs894160, found in a gene that helps control how the body releases fat from storage. We want to find out whether people with different versions of this gene lose weight at different rates, or with different success, when they follow the same low-carbohydrate, reduced-calorie diet.
Who can participate?
Palestinian adults aged 18–65 years who are overweight or obese (body mass index 27 kg/m² or above), who have already had PLIN1 rs894160 genetic testing done at Gene Medical Lab, and who are willing to follow a 12-week diet plan.
What does the study involve?
Participants will follow a personalised low-carbohydrate, reduced-calorie diet for 12 weeks. Everyone follows the same type of diet; there is no comparison group receiving a different diet or a placebo. Body weight is measured at the start, at week 6, and at week 12. Every 2 weeks, participants meet the researcher to check their weight, answer questions about what they have eaten in the last 24 hours, and have a simple urine test. Existing genetic results and, where available, blood test results (glucose, cholesterol) already on file are used; no new blood or genetic samples are taken for this study.
What are the possible benefits and risks of participating?
Participants may benefit from structured dietary guidance and monitoring aimed at healthy weight loss. Risks are those normally associated with a supervised calorie-restricted diet, such as tiredness or hunger, and are minimised through regular monitoring by the researcher and a supervising physician.
Where is the study run from?
Gene Medical Lab, a private clinical genetics laboratory in Palestine, together with Al-Azhar University – Gaza (Faculty of Applied Medical Sciences, Master Program of Clinical Nutrition).
When is the study starting and how long is it expected to run for?
October 2026 to January 2027
Who is funding the study?
Al-Azhar University – Gaza (Palestine)
Who is the main contact?
Omar Ayesh, omarsuhailayesh@gmail.com
Contact information
Principal investigator, Public
Gaza Strip
Al Nasser Street
Gaza
P850
Palestine, State of
| Phone | +972 (0)592189971 |
|---|---|
| omarsuhailayesh@gmail.com |
Scientific
Building I06, Room SA2.29, University Street, Al Tarfa
Doha
12572
Qatar
| Phone | +974 (0)4403 7505 |
|---|---|
| reema.tayyem@qu.edu.qa |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | Association of PLIN1 rs894160 polymorphism with weight-loss among Palestinian adults with overweight and obesity undergoing a low-carbohydrate, reduced-calorie dietary intervention |
| Study acronym | PLIN1-LCRCD |
| Study objectives | 1. To assess the association between PLIN1 rs894160 genotype and weight loss velocity (kg/week) during the LC-RCD dietary intervention, and to compare the rate of weight reduction across the three genotype groups (GG, GA, AA). 2. To evaluate the association between PLIN1 rs894160 genotype and the overall success of weight reduction at the end of the dietary intervention period, and to compare success rates across genotype groups. 3. To examine the effect of age, sex, baseline BMI, and biochemical data on the association between PLIN1 rs894160 genotype and both weight loss velocity and overall weight reduction success. 4. To determine the genotype and allele frequency distribution of the PLIN1 rs894160 polymorphism (GG, GA, AA genotypes) in the Palestinian adult population. 5. To estimate the magnitude of genotype-associated differences in weight-loss outcomes, as a preliminary step toward future validation of PLIN1 rs894160 as a candidate marker for personalized nutrition. |
| Ethics approval(s) |
Approved 03/08/2026, Palestinian Health Research Council (Department of Clinical and Therapeutic Nutrition, Al-Azhar University – Gaza, Gaza, P850, Palestine, State of; +972 (0)599 784 862; mohammed.lulu@alazhar.edu.ps), ref: PHRC\HC\1452\26 |
| Health condition(s) or problem(s) studied | Overweight and obesity |
| Intervention | All eligible participants receive the same standardised 12-week Low-Carbohydrate, Reduced-Calorie Diet (LC-RCD): an individually calculated carbohydrate target (60–130 g/day, ±10–15 g tolerance) combined with a personalised caloric deficit of 500–750 kcal/day below estimated total daily energy expenditure (Mifflin-St Jeor equation). Participants are stratified by pre-existing PLIN1 rs894160 genotype (GG, GA, AA) obtained from prior clinical testing at Gene Medical Lab; no randomisation is performed, as genotype occurs naturally. Body weight and BMI are measured at baseline (week 0), midpoint (week 6) and end of intervention (week 12). Biweekly follow-up visits (weeks 2, 4, 6, 8, 10) include weight measurement, urinary ketone testing, and a structured 24-hour dietary recall interview conducted by the principal researcher in collaboration with a supervising physician. Total duration of intervention and follow-up is 12 weeks per participant. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 1100 |
| Key inclusion criteria | 1. Palestinian adults aged 18–65 years 2. Overweight or obese individuals with body mass index (BMI) ≥27 kg/m² 3. Available PLIN1 rs894160 genotype result from Gene Medical Lab 4. Willingness to adhere to the 12-week LC-RCD dietary protocol 5. Provision of informed consent |
| Key exclusion criteria | 1. Presence of severe chronic illness that may independently affect metabolism or weight, including active malignancy, chronic kidney disease, or hepatic disease 2. Current use of medications known to affect body weight or lipid metabolism, including corticosteroids, antipsychotics, or weight-loss medications 3. Pregnancy or lactation 4. Prior bariatric surgery 5. Multiple prior dietary attempts (history of repeated dieting before the study) 6. Incomplete baseline anthropometric data |
| Date of first enrolment | 01/10/2026 |
| Date of final enrolment | 30/10/2026 |
Locations
Countries of recruitment
- Palestine, State of
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
21/09/2026: Study's existence confirmed by the Palestinian Health Research Council.
