Effects of fasting on your body may differ according to your genes

ISRCTN	ISRCTN18205186
DOI	https://doi.org/10.1186/ISRCTN18205186

Submission date: 10/06/2021
Registration date: 16/06/2021
Last edited: 16/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Haptoglobin is a protein produced by the liver that the body uses to clear free hemoglobin (found outside of red blood cells) from circulation.
Serum haptoglobin (Hp) is an acute-phase protein that is crucial for the neutralization of oxidative damage and the elimination of free hemoglobin. The current study aimed to examine the impact of observing four consecutive weeks, dawn to sunset intermittent fasting (IF) among people with overweight and obesity.

Who can participate?
Any metabolically healthy male or female adult subject (>18 years) with overweight/obesity (BMI>25 kg/m²), willing to fast for consecutive four weeks from dawn to sunset, and willing to participate and sign the informed consent.

What does the study involve?
The study involves observing the body weight changes, blood inflammatory, and biochemical metabolic measurement before and after the commencement of four-week consecutive dawn to sunset intermittent fasting.

What are the possible benefits and risks of participating?
The study will benefit the participant in controlling his body weight and body composition, inflammatory and metabolic markers related to chronic diseases over two months (before and after the commencement of IF). Many beneficial metabolic and inflammatory improvements are expected to gain by the participants according to the available literature on IF. No harm is expected after observing IF for one month, as IF 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 (UAE)

When is the study starting and how long is it expected to run for?
December 2015 to October 2016

Who is funding the study?
Sharjah University (UAE)

Who is the main contact?
Dr. Moez AlIslam Faris, mfaris@sharjah.ac.ae

Contact information

Prof MoezAlIslam Faris
Scientific

University of Sharjah
Sharjah
27272
United Arab Emirates

ORCID ID	0000-0002-7970-2616
Phone	+971562979628
Email	moezfaris@hotmail.com

Study information

Study design	Observational prospective cohort
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/198rkJ888dieP1OTvhWpaCAnb5nhcLvFH/view
Scientific title	Impact of four consecutive weeks, dawn to sunset intermittent fasting on CD163 and haptoglobin inflammatory markers among haptoglobin polymorphisms in overweight/obese subjects
Study acronym	RAMFAST
Study objectives	Impact of four consecutive weeks, dawn to sunset intermittent fasting on CD163, and haptoglobin inflammatory markers in overweight/obese subjects will differ according to the haptoglobin polymorphisms
Ethics approval(s)	Approved 15/05/2016, Research Ethics Committee, University of Sharjah (Sharjah 27272, UAE; +971 65057304; rec@sharjah.ac.ae), ref: REC/15/12/16/002
Health condition(s) or problem(s) studied	Prevention of inflammatory and metabolic complications in metabolically healthy overweight and obese subjects
Intervention	Volunteers willing to participate and practice intermittent fasting for four consecutive weeks from dawn to sunset were recruited. Body weight, height, and body measurements, blood samples and food intakes were taken one week before the commencement of intermittent fasting, and after completing the four consecutive weeks of intermittent fasting. Total duration of the fasting was consecutive 29-30 days. No follow-up after completing the four weeks intermittent fasting.
Intervention type	Behavioural
Primary outcome measure	Measured using blood test: 1. Haptoglobin gene polymorphism genotype (fixed outcome), serum CD136, and serum haptoglobin were determined at baseline 2. Serum CD136, and serum haptoglobin levels were measured after four-week consecutive intermittent fasting
Secondary outcome measures	Measured at baseline, and after four weeks intermittent fasting: 1. Body weight (kg), BMI (kg/m²) 2. Inflammatory (IL-6, TNF-alpha, IL-10) and metabolic markers (lipid profile, glucose homeostasis) measured using blood test
Overall study start date	01/12/2015
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	65
Key inclusion criteria	1. Metabolically healthy male or female adult subject (>18 years) 2. Overweight/obesity (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

University of Sharjah

Research Institute for Medical and Health Sciences
University City Of Sharjah
Sharjah
27272
United Arab Emirates

Sponsor information

University of Sharjah
University/education

University city of Sharjah
Sharjah
27272
United Arab Emirates

Phone	+97165057514
Email	smirza@sharjah.ac.ae
Website	https://www.sharjah.ac.ae/en/Pages/default.aspx
"ROR"	https://ror.org/00engpz63

Funders

Funder type

Not defined

University of Sharjah
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 available from the corresponding author on reasonable request. MoezAlIslam 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 received, and for one-week By what access criteria data will be shared including with whom? By Drop Box repository special link 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 is used. Any ethical or legal restrictions, any other comments: Data were obtained following the Helsinki Declaration for research ethics_

Editorial Notes

11/06/2021: Trial's existence confirmed by University of Sharjah.