Effects of Ramadan fasting on cholesterol-metabolizing protein PCSK9 in people with obesity
| ISRCTN | ISRCTN87587044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87587044 |
- Submission date
- 18/06/2021
- Registration date
- 28/09/2021
- Last edited
- 18/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diet changes are important to help patients to lower their high blood cholesterol. One of the factors that affect blood cholesterol is a blood protein called PCSK9, which helps in regulating blood cholesterol, so some medications try to affect this protein in an attempt to lower blood cholesterol. Abstinence from food and drink for a specific time period is called intermittent fasting. This type of fasting has been shown to have beneficial effects on human health and disease. Thus, the aim of this study is to find out whether practising fasting during the holy month of Ramadan can affect the PCSK9 protein in adult healthy Muslims.
Who can participate?
Healthy adults (aged over 18 years) with overweight/obesity (BMI >25 kg/m²), willing to fast for 4 consecutive weeks from dawn to sunset
What does the study involve?
The study involves observing the changes in body weight and blood test results before and after 4 weeks of dawn to sunset intermittent fasting.
What are the possible benefits and risks of participating?
The study may benefit help participants to control their body weight, body composition and inflammatory and metabolic markers related to chronic diseases. No harm is expected from intermittent fasting for 1 month, as intermittent fasting is considered safe for metabolically healthy overweight and obese people with no predetermined diseases. The participant may experience slight discomfort due to blood sampling.
Where is the study run from?
University Hospital of Sharjah, Sharjah University (United Arab Emirates)
When is the study starting and how long is it expected to run for?
November 2015 to October 2016
Who is funding the study?
The University of Sharjah (United Arab Emirates)
Who is the main contact?
Dr Moez Al-Islam Faris
mfaris@sharjah.ac.ae
Contact information
Scientific
University of Sharjah
Sharjah
27272
United Arab Emirates
 ORCID ID |
0000-0002-7970-2616 |
|---|---|
| Phone | +971 (0)562979628 |
| mfaris@sharjah.ac.ae |
Scientific
University of Sharjah
Sharjah
27272
United Arab Emirates
| Phone | +971 (0)562979628 |
|---|---|
| moezfaris@hotmail.com |
Study information
| Study design | Observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | https://drive.google.com/file/d/1ff8dAUXffnPkJiUbuP5ZuyAzZTfzMkHX/view?usp=sharing |
| Scientific title | Association of Ramadan intermittent fasting with changes in circulating proprotein convertase subtilisin/kexin type 9 (PCSK9) in metabolically healthy obese subjects |
| Study acronym | RAMFAST |
| Study objectives | Four consecutive weeks, dawn to sunset intermittent fasting will lead to changes in circulating PCSK9 cholesterol metabolism marker in people with obesity |
| Ethics approval(s) | Approved 29/11/2015, Research Ethics Committee, The University of Sharjah (Sharjah 27272, UAE; +971 (0)65057304; rec@sharjah.ac.ae), ref: ERC 29/11/15/49 |
| Health condition(s) or problem(s) studied | Prevention of elevated cholesterol by lowering circulating PCSK9 in metabolically healthy people with obesity |
| Intervention | Volunteers willing to participate and practice intermittent fasting for 4 consecutive weeks from dawn to sunset are recruited. Body weight, height, and body measurements, blood samples and food intake are measured 1 week before the commencement of intermittent fasting, and after completing the 4 consecutive weeks of intermittent fasting. The total duration of the fasting is 29-30 consecutive days. There is no follow-up after completing the 4 weeks of intermittent fasting. |
| Intervention type | Behavioural |
| Primary outcome measure | Blood PCSK9 levels measured using enzyme-linked immunosorbent assay (ELISA) at baseline (pre-fasting) and after 4-week consecutive dawn to sunset intermittent fasting |
| Secondary outcome measures | Measured using Analyzer machine at baseline, and after 4 weeks intermittent fasting: 1. Body weight (kg), BMI, fat mass, fat-free mass, and visceral fat surface area 2. Total cholesterol, triglycerides, HDL, LDL, fasting blood glucose |
| Overall study start date | 29/11/2015 |
| Completion date | 01/10/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Metabolically healthy male or female adult subject (>18 years) 2. Overweight/obesity (body mass index (BMI) >25 kg/m²) 3. Willing to fast for consecutive four weeks from dawn to sunset, and willing to participate and sign the informed consent |
| Key exclusion criteria | 1. History of metabolic syndrome, diabetes, or cardiovascular disease 2. Taking regular medications or supplements 3. Following a weight-reducing diet 4. History of bariatric surgery within the last 6-9 months before commencing intermittent fasting 5. Pregnant or peri-menopausal woman |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 15/06/2016 |
Locations
Countries of recruitment
- United Arab Emirates
Study participating centre
Sharjah
27272
United Arab Emirates
Sponsor information
University/education
Sharjah University City
Sharjah
27272
United Arab Emirates
| Phone | +971 (0)65157514 |
|---|---|
| mfaris@sharjah.ac.ae | |
| Website | https://www.sharjah.ac.ae/en/Pages/default.aspx |
"ROR" |
https://ror.org/00engpz63 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- جامعة الشارقة, jāmiʿat aš-šāriqah, The University of Sharjah, UOS
- Location
- United Arab Emirates
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Moez Al-Islam Faris (mfaris@sharjah.ac.ae). Type of data: raw data, master Excel sheet. When the data will become available and for how long: will be available once the request is received for 1 week By what access criteria data will be shared including with whom: by DropBox repository special link that can only be opened by those who have the link For what types of analyses: only for secondary and meta-analysis, not for original work re-analysis Whether consent from participants was obtained: yes, obtained Comments on data anonymization: all data are anonymized, no names or any personal identification information are used. Any ethical or legal restrictions, any other comments: data were obtained following the Helsinki Declaration for research ethics. |
Editorial Notes
18/06/2021: Trial's existence confirmed by the University of Sharjah.
