An interventional study of Placebo and Protein in Overweight and Obese Adults and BMI>=23 kg/m2, sponsored by Nanyang Technological University. Completed at 1 site in Singapore. Open to male participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Nanyang Technological University · Not applicable, Interventional, and Treatment
Overweight and obesity are part of a global health epidemic. However, older adults trying to lose weight face a dual challenge: first, muscle mass and strength naturally decline at an accelerating rate with age; second, effective weight loss diets like alternate-day fasting (ADF) are typically accompanied by significant muscle loss. Together, these factors can increase the risk of developing sarcopenia, a muscle disease characterized by critical losses in muscle mass and strength, especially when overweight or obese older adults try to lose weight through dieting alone. While high protein diets have often been advocated as a muscle preserving strategy when losing weight, recently, high leucine intake has been promoted for its critical role in stimulating muscle protein synthesis (MPS) with lower overall protein consumption, potentially reducing calorie intake while maintaining muscle during weight loss. Nonetheless, the effects of body mass-scaled protein and leucine intakes on muscular outcomes during weight loss remain uncertain. This study examines the effects of body mass-scaled protein and leucine supplementation on body composition during four weeks of ADF in older men.
Participation in this study requires a total of 4 weeks of alternate day fasting (ADF) and 3 laboratory visits (sessions) spread over 5-6 weeks. All sessions are done in a fasted and rested state. Participants will complete 4 weeks of ADF alternating between ad libitum feeding days and fasting days consisting of a small midday meal of up to 600 kcal. Supplements will be provided to participants (3 servings on feeding days and 1 serving on fasting day).
Prior to each session, participants are required to:
Session 1
Pre-screening:
Session 2 The 4-week alternate-day fasting programme will start within 14 days from session 1
Session 3 28 days (4 weeks) after the start of alternate-day fasting
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's enrollment of 80 is close to the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Nanyang Technological University is the lead sponsor of 52 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria (any of the criteria):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal
Dietary Supplement: Placebo
0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal
Dietary Supplement: Protein
0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal
Dietary Supplement: Leucine
Control (placebo supplements) 0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal
Protein supplements: 0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal
Leucine supplementation: 0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal
Body Mass
Time frame: Start and end of 4-week intervention
Lean Mass
Time frame: Start and end of 4-week intervention
Appendicular Lean Mass
Sum of lean mass in upper and lower limbs
Time frame: Start and end of 4-week intervention
Body mass index
body mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Lean mass index
lean mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Appendicular lean mass index
Appendicular lean mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Fat mass
Time frame: Start and end of 4-week intervention
Percentage body fat
Time frame: Start and end of 4-week intervention
Fat mass index
Fat mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Trunk fat
Fat mass around the trunk
Time frame: Start and end of 4-week intervention
Appendicular fat mass
Sum of fat mass in the upper and lower limbs
Time frame: Start and end of 4-week intervention
Appendicular fat mass index
Appendicular fat mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Resting systolic blood pressure
Time frame: Start and end of 4-week intervention
Resting diastolic blood pressure
Time frame: Start and end of 4-week intervention
Fasting blood glucose
Time frame: Start and end of 4-week intervention
HbA1c
Time frame: Start and end of 4-week intervention
Insulin
Time frame: Start and end of 4-week intervention
HOMA-IR
Time frame: Start and end of 4-week intervention
Total cholesterol
Time frame: Start and end of 4-week intervention
HDL cholesterol
Time frame: Start and end of 4-week intervention
LDL cholesterol
Time frame: Start and end of 4-week intervention
Total cholesterol to HDL cholesterol ration
Time frame: Start and end of 4-week intervention
Triglycerides
Time frame: Start and end of 4-week intervention
Android fat
fat around stomach
Time frame: Start and end of 4-week intervention
Gynoid fat
fat around hips and mid section
Time frame: Start and end of 4-week intervention
Bone mineral content
Time frame: Start and end of 4-week intervention
bone mineral density
Time frame: Start and end of 4-week intervention
Waist Circumference
Time frame: Start and end of 4-week intervention
Hip circumference
Time frame: Start and end of 4-week intervention
Waist-to-hip ratio
Time frame: Start and end of 4-week intervention
Fat free mass
Fat free mass measured using BIA
Time frame: Start and end of 4-week intervention
Skeletal muscle mass
Skeletal muscle mass measured using BIA
Time frame: Start and end of 4-week intervention
Appendicular fat-free mass
Sum of fat free mass in upper and lower limbs measured using BIA
Time frame: Start and end of 4-week intervention
Visceral fat area
Visceral fat area measured using BIA
Time frame: Start and end of 4-week intervention
Fat-free mass index
Fat-free mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Skeletal muscle mass index
Skeletal muscle mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Appendicular fat-free mass index
Appendicular fat-free mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Insulin growth factor-1
Time frame: Start and end of 4-week intervention
Mood
Brunel Mood Scale (BRUMS). BRUMS is the modified and shorter version of the Profile of Mood Stats (POMS). The 24-item BRUMS was used to assess mood responses. It has six subscales (tension, depression, anger, vigour, fatigue, and confusion) of four mood descriptors each, with respondents rating how they feel "right now" on a 5-point Likert-type scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit; 4 = extremely). During its development, the BRUMS showed robust psychometric properties across samples of adult students, adult athletes, young athletes, and schoolchildren, and has since demonstrated psychometric integrity for use with many other population groups (doi.org/10.3390/su13116116).For each subscale, the raw score are summed and converted to a T-score based on the norms published in the paper (doi.org/10.3390/su13116116). Higher T-score for each subscale reflects higher profile of that subscale (i.e. tension, depression, anger, vigour, fatigue, or confusion).
Time frame: Start and end of 4-week intervention
Food craving - habitual
The Food Craving Questionnaire-Trait Reduced (FCQ-T-r) measures the habitual (unspecified time frame) trait craving for food in general. It predicts food cravings in daily life. It represents a stable trait but is also sensitive to changes in eating behaviour. The questionnaire consists of 15 questions, participants are required to rate the frequency of each statement with a 6-likert scale (never or not applicable = 1, to always = 6). By summing up the scores of the scales, higher scores represent higher level of food cravings.
Time frame: Start and end of 4-week intervention
Food craving - specific foods
Food Craving Inventory (FCI) measures food craving for specific foods and the versions validated for use in United States and United Kingdom were used. Questionnaire items pertaining to specific local foods were also added for a combined total of 61 food items (i.e. questionnaire items). For each item, participants were asked how often they have experienced a craving for that particular food on a 5-point Likert scale (never = 1, to always/almost every day = 5). The higher the score, the higher the food craving.
Time frame: Start and end of 4-week intervention
Eating Behaviour
Three-Factor Eating Questionnaire-R18 - cognitive restraint component (TFEQ-r18 Cog). It has 6 items and each scored 1 to 4 for a total of 24 points. The higher the total score, the more disordered the eating behaviour.
Time frame: Start and end of 4-week intervention
Hunger over past 4 weeks
Hunger over past 4 weeks. Visual analogue scale 0 to 100. The higher the number the greater the amount of hunger.
Time frame: Start and end of 4-week intervention
Baseline appetite
Baseline appetite using visual analogue scale 0 to 100. The higher the score, the higher the baseline appetite
Time frame: Start and end of 4-week intervention upon arrival in the laboratory
Satiety over past 4 weeks
Satiety over past 4 weeks. Visual analogue scale 0 to 100. The higher the number, the greater amount of satiety.
Time frame: Start and end of 4-week intervention
Diet satisfaction over past 4 weeks
Diet satisfaction over past 4 weeks. Visual analogue scale 0 to 100. The higher the number the greater the satisfaction.
Time frame: Start and end of 4-week intervention
Implicit satiety goal
mplicit satiety goal (unconscious, habitual, or subjective levels of fullness that individuals aim to achieve when eating) using visual analogue scale 0 to 100. The higher the number, the greater implicit satiety goal.
Time frame: Start and end of 4-week intervention
Ideal portion size
Ideal portion size (IPS). Participants were presented with a diverse range of 25 foods typically consumed in Singapore. The computerised portion selection tasks presented a series of 50 images of each food that increased in portion size in 20 kcal increments (20-1000 kcal). Participants could increase or decrease the portion size by 20 kcal using the left and right arrow-keys on the keyboard and were encouraged to view the full range of portions before selecting their ideal portion. Foods were presented in a randomised order and an average portion size for each participant was calculated by averaging the selected portion sizes of all 25 foods (α = 0.95). This created an overall index of IPS.
Time frame: Start and end of 4-week intervention
Expected satiety
Expected satiety (ES) measured using computerised task. The ES task followed the same format as the IPS task, in other words, 50 images were presented depicting 20 kcal increment changes in portion size. This task sought to measure participants' expectations about how satiating a diverse range of foods were. Larger portions selected indicated that participants require larger quantities of the food to delay the onset of hunger, in other words they have lower expected satiety. The same 25 foods presented in the IPS were also presented in the ES in a randomised order and were averaged to create an overall index of ES (α = 0.95).
Time frame: Start and end of 4-week intervention
Food-related characteristics
A single image of each food item was presented to participants alongside questions of food-related characteristics. Participants were asked to rate how filling they expected each food to be (not filling at all (0) to very filling (100)), how much they like each food in general (not at all (0) to very much (100)) and how often they eat each food (never (0) to more than once a week (5)). Each food was presented in a randomised order and average scores across all 25 foods for participants perceptions of how filling, frequently consumed and preference for foods were calculated.
Time frame: Start and end of 4-week intervention
Handgrip strength
Measurement of handgrip strength using a handheld dynamometer
Time frame: Start and end of 4-week intervention
Short physical performance battery
Standardised physical performance test
Time frame: Start and end of 4-week intervention
6m gait speed
Gait speed over 6m
Time frame: Start and end of 4-week intervention
Height
Time frame: Start and end of 4-week intervention
Hydration status
Intracellular water (litre)/extracellular water (litre). This ratio is a reflection of the hydration status in the body. Hydration status can affect the body composition measurements using BIA.
Time frame: Start and end of 4-week intervention
SGP/ALT
blood biomarker of liver function
Time frame: Start and end of 4-week intervention
SGOT/AST
blood biomarker of liver function
Time frame: Start and end of 4-week intervention
Serum sodium
Time frame: Start and end of 4-week intervention
Serum potassium
Time frame: Start and end of 4-week intervention
Serum urea
Time frame: Start and end of 4-week intervention
Serum creatinine
Time frame: Start and end of 4-week intervention
Full blood count
Time frame: Start and end of 4-week intervention
Weekly physical activity level
Participants complete the type, intensity and duration of each physical activity during the week similar to Global Physical Activity Questionnaire (GPAQ) developed by the WHO. Each activity is calculated in Metabolic Equivalent (MET) value. Moderate MET value is 4.0 and vigorous MET value is 8.0 while for transport domains MET value is 4.0.
Time frame: 1-2 weeks before the start of the intervention and for each week of the 4-week intervention
Food diary
Participants have to record their food intake on 4-day/week
Time frame: 4-day/week during the 4-week intervention
Sleep diary
Participants have to log their sleep time, wake up time and subjective sleep quality daily
Time frame: Daily during the 4-week intervention
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Jun 2023, 7 months.
Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 7 months is below that.
Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Proteins · Leucine
Nanyang Technological University