NCT07241689

Brief Summary

The objectives of this study are to examine the effects of protein supplementation on 4 weeks of alternate-day fasting (ADF) on fasting blood glucose, resting blood pressure, and body composition in young Asian men with unhealthy body mass index ≥ 23 kg/m2. To achieve the objective, 40 young men aged 21 to 35 years old will be recruited to participate in this study and complete a 4-week ADF programme. The fasting programme starts at 12 midnight and alternates between fasting and feeding days. Each fasting or feeding day is 24-hour in duration. On fasting days, no food and beverages are allowed except for ad libitum intake of plain water and/or other zero-calorie beverages, and a small meal between 400-600 kcal. In this study, participants would be randomly assigned to either the control or protein supplementation group (20 in each group). The control group will consume a small meal of their choice as long as it is between 400-600 kcal while the protein supplementation group will consume a small meal between 400-600 kcal that will include a protein supplement that would be provided (125 kcal, 25 g protein) and with the remainder of the meal of their choice. For both groups in this study, the small meal is to be consumed during 12 pm to 2 pm for standardisation to ensure consistency in total duration of fasting and feeding. The programme will end after 4 weeks (28 days) of continuous alternate-day fasting. Fasting blood glucose, resting blood pressure and heart rate, body mass, height, and body composition will be measured before and after 4-week of ADF. In addition, these measurements, except body composition, will be repeated at the end of each week of ADF. The research hypothesis are: 1) 4 weeks of ADF will reduce body mass via both fat and muscle loss, and improve health indices as measured by fasting blood glucose and resting blood pressure in young individuals with BMI greater than the desired healthy range, and 2) protein supplementation during fasting days will reduce muscle loss during loss of body mass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 13, 2025

Last Update Submit

November 18, 2025

Conditions

Obesity & Overweight

Keywords

overweightobesityintermittent fastingalternate-day fastingbody compositionmusclefatblood pressureblood glucoseprotein supplementationweight loss

Outcome Measures

Primary Outcomes (12)

  • Body mass

    Body mass - a component of body composition.

    Start and end of 4-week intervention

  • Fat mass

    A component of body composition. Total amount of fat mass.

    Start and end of 4-week intervention

  • Fat-free mass

    A component of body composition. Total amount of fat-free mass, which is the total body mass excluding fat. It consists of primarily skeletal muscle mass, and also bone mass.

    Start and end of 4-week intervention

  • Skeletal muscle mass

    A component of body composition. Total amount of skeletal muscle mass.

    Start and end of 4-week intervention

  • Appendicular fat-free mass

    A component of body composition. Sum of skeletal muscle mass in the upper and lower limbs.

    Start and end of 4-week intervention

  • Percentage body fat

    A component of body composition. Percentage of body mass that is made up of fat mass.

    Start and end of 4-week intervention

  • Visceral fat area

    A component of body composition. Amount of visceral fat - a measurement of fat around abdominal organs.

    Start and end of 4-week intervention

  • Body mass index

    A component of body composition. Computed from the measured body mass in kilograms divided by the square of height in metres.

    Start and end of 4-week intervention

  • Fat mass index

    A component of body composition. Total fat mass in kilograms divided by square of height in metres.

    Start and end of 4-week intervention

  • Fat-free mass index

    A component of body composition. Total fat-free mass in kilograms divided by square of height in metres.

    Start and end of 4-week intervention

  • Skeletal muscle mass index

    A component of body composition. Total skeletal muscle mass divided by square of height in metres.

    Start and end of 4-week intervention

  • Appendicular fat-free mass index

    A component of body composition. Total appendicular fat-free mass in kilograms divided by square of height in metres.

    Start and end of 4-week intervention

Secondary Outcomes (2)

  • Fasting blood glucose

    Weekly from start to end of 4-week intervention

  • Resting blood pressure

    Weekly from start to end of 4-week intervention

Other Outcomes (2)

  • Hydration status

    Start and end of 4-week intervention

  • Physical activity level

    Weekly from start to end of 4-week intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard ADF protocol of a small meal of their choice between 400-600 kcal on 12-2pm during fasting days

Other: No supplementation

Protein

EXPERIMENTAL

ADF protocol of a small meal between 400-600 kcal including the protein supplement (125 kcal, 25 g protein) that is provided and with the remainder of the meal of their choice on 12-2pm during fasting days

Dietary Supplement: protein supplement

Interventions

protein supplementDIETARY_SUPPLEMENT

Protein supplement in the form of a whey protein powder containing 25 g of protein and 125 kcal that is provided during the fasting days

Protein
No supplementationOTHER

Standard ADF protocol of a small meal of their choice between 400-600 kcal during fasting days

Control

Eligibility Criteria

Age21 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • to 35 years old
  • Do not smoke or use tobacco products (including shisha)
  • Have a body mass index (BMI = body mass in kilograms divided by the square of height in metres) of 23 or greater

You may not qualify if:

  • One cannot participate in or will be released from this study if any of the following conditions or situations applies to them:
  • Unable to adhere to requirements regarding physical activity and diet as stated in the methods
  • Failed an exercise stress test
  • Have any health condition(s) that would be made worse by fasting
  • Taking long-term prescribed medication(s) for heart, blood (including blood glucose and blood pressure), lung (except controlled asthma), liver, kidney or joint condition(s)
  • Taking other long-term prescribed medication (including traditional Chinese Medicine and other alternative medicine) that are known to affect any of the measurements in this study
  • Allergic or intolerant to milk and soy (the protein supplement that participant may be required to consume, contains milk proteins and traces of soy lecithin and lactose)
  • Have an artificial electrical implant such as a defibrillator or pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanyang Technological University

Singapore, Singapore

Location

MeSH Terms

Conditions

ObesityOverweightIntermittent FastingPlatelet Glycoprotein IV DeficiencyWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehaviorBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 21, 2025

Study Start

January 17, 2018

Primary Completion

March 23, 2018

Study Completion

March 23, 2018

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

IPD sharing will be available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Access Criteria
Individual participant data (IPD) will be made available to qualified researchers upon request. To access the data, researchers must submit a formal request, which will be reviewed and approved by the data sharing committee. Data access will be granted for research purposes only and will require adherence to data use agreements and ethics guidelines.

Locations

SG(1)