Investigating the effects of low saturated fat ketogenic diet on lipaemia in lean and obese healthy participants in Kuwait
| ISRCTN | ISRCTN30944171 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30944171 |
- Submission date
- 03/12/2024
- Registration date
- 16/04/2025
- Last edited
- 28/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
This study aims to explore the effects of different diets on health markers such as cholesterol levels and blood pressure. Researchers hope to understand how diet can influence these markers in both lean and obese individuals.
Who can participate?
Participants can be men or women aged between 18 and 60 years. They should either be lean (with a BMI between 18.5 and 24.9 kg/m²) or obese (with a BMI above 29.9 kg/m²). Participants must be willing to follow a specific diet for the duration of the study and be able to provide informed consent. They should not be taking lipid-lowering or blood pressure medications.
What does the study involve?
Participants will follow a specific diet plan provided by the researchers. They will have regular check-ups to monitor their health markers, such as cholesterol levels and blood pressure. The study will involve dietary assessments and possibly blood tests to track changes over time.
What are the possible benefits and risks of participating?
Participants may benefit from gaining insights into their health and how their diet affects it. However, there are risks such as potential side effects from dietary changes, and the inconvenience of regular check-ups and tests.
Where is the study run from?
University of Aberdeen (UK)
When is the study starting and how long is it expected to run for?
September 2024 to December 2025
Who is funding the study?
Dasman Diabetes Institute (Kuwait)
Who is the main contact?
habooots@gmail.com
f.thies@abdn.ac.uk
Contact information
Scientific, Principal Investigator
School of Medicine, medical Sciences and Nutrition, Rowett Institute, Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
 ORCID ID |
0000-0002-9275-9713 |
|---|---|
| Phone | +44 (0)1224 437954 |
| f.thies@abdn.ac.uk |
Public, Scientific
Qadiseya block 9 st 92 house 16
Asimah
-
Kuwait
| ORCID ID |
0009-0002-0918-5024 |
|---|---|
| Phone | +965 65555551 |
| r01hb23@abdn.ac.uk |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Investigating the effects of low saturated fat ketogenic diet on lipaemia in lean and obese healthy participants in Kuwait |
| Study acronym | IESFKD |
| Study hypothesis | To determine the effect of low- and high- saturated fat ketogenic diets on lipid profile and microbiota in lean and obese healthy participants in Kuwait |
| Ethics approval(s) |
Approved 30/09/2024, Dr. Fatmah Abdul Rahman AlNajjar (Kuwait Public Health Ministry, Asimah, -, Kuwait; 1810005; appsupport@moh.gov.kw), ref: 1601 |
| Condition | The effect of low or high saturated fat ketogenic diet on lipidemia |
| Intervention | A randomized parallel clinical trial will be conducted for 4 weeks to assess the impact of high and low saturated fat KD (SFKD) on lipid profile and microbiota of healthy lean and obese participants. - The high SFKD will consist of approximately 70-75% fat (40% saturated fat), 20-25% protein (1.7 grams/kg), and 5-10% carbohydrate (less than 100 grams/day). - The low SFKD will consist of approximately 70-75% fat (10% saturated fat), 20-25% protein (1.7 grams/kg), and 5-10% carbohydrate (less than 100 grams/day). Participants are randomized using an online tool. |
| Intervention type | Other |
| Primary outcome measure | Lipid profile from baseline (Week 1) and (week 4) though blood samples |
| Secondary outcome measures | 1. Triglyceride, HDL, glucose,and insulin sensitivity will be measured by blood sample at baseline (week 1) and at (week 4) 2. Gut microbiome activity and composition will be through stool sample collection from week 1 and week 4 3. Body composition measured using DEXA at week 1 and week 4. For blood pressure it will be measured at week 1 and week 4 |
| Overall study start date | 30/09/2024 |
| Overall study end date | 01/12/2025 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 96 |
| Participant inclusion criteria | 1. Age between 18 and 60 years 2. Male or female participants 3. Lean group: BMI between 18.5 and 24.9 kg/m² 4. Obese group: BMI above 29.9 kg/m² 5. Willingness to adhere to the assigned diet for the duration of the study 6. Ability to provide informed consent 7. No use of lipid-lowering medication 8. No use of blood pressure medication |
| Participant exclusion criteria | 1. For lean participants, elevated lipid profile defined by total cholesterol above 5.2 mmol/L and LDL above 3.5 mmol/L with triglyceride HDL ratio between 4.0 to 6.0. For obese participants, total cholesterol above 6 mmol/L and LDL above 5 mmol/L 2. Cardiovascular diseases 3. Eating disorder 4. Diagnosed with hypertension (above 140/90 mmHg) and taking blood pressure medications such as ACE inhibitors, calcium channel blockers, or diuretics 5. Being pregnant 6. Food allergies 7. Inflammatory bowel disease 8. Irritable bowel syndrome 9. Non-alcoholic fatty liver |
| Recruitment start date | 01/12/2024 |
| Recruitment end date | 01/12/2024 |
Locations
Countries of recruitment
- Kuwait
Study participating centre
Sharq, Block 3, P.O. Box 1180 Dasman
Asimah
1180
Kuwait
Sponsor information
University/education
University of Aberdeen
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Phone | +44 (0)1224 272000 |
|---|---|
| pgr-mmsn@abdn.ac.uk | |
| Website | http://www.abdn.ac.uk/ |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Dasman Institute, DDI
- Location
- Kuwait
Results and Publications
| Intention to publish date | 18/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from f.thies@abdn.ac.uk |
Editorial Notes
28/03/2025: Trial's existence confirmed by Kuwait Public Health Ministry.
