Overweight and Obese AdultsNCT07781410
Role of Leucine on Muscle Preservation During Weight Loss in Older Men
A study testing Protein and Leucine in people with Overweight and Obese Adults and BMI>=23 kg/m2, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Overweight and Obese Adults, BMI>=23 kg/m2
- What is being tested?
- Protein and Leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Nov 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Of Asian descent
- 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) ≥ 23 kg/m2
Who cannot join
- Unable to adhere to the requirements regarding physical activity and diet as stated in the research methodologies. All supplements; including but not limited to vitamins, minerals, amino acids and proteins; which are not provided by this research, and traditional Chinese medicine are not allowed.
- Vegetarians or vegans due to potential differences in responses and that the supplements provided may contain dairy products.
- Allergic or intolerant to milk. The supplement that you will be required to consume may contain milk proteins, and lactose (milk sugar).
- Failed an exercise stress test.
- Have any health condition(s) that would be made worse by fasting.
- History of familial leucine-sensitive hypoglycaemia, i.e., highly symptomatic hypoglycaemia triggered by protein meals or the amino acid, leucine.
Show all 14Show fewer
- Have diabetes, pre-diabetes, or abnormally high fasting blood glucose (> 6.0 mmol/L).
- Have uncontrolled hypertension (≥ 150/90 mmHg for ≥ 80 years old, ≥ 140/90 mmHg for < 80 years old).
- Have liver or kidney conditions.
- Have existing musculoskeletal conditions that could be exacerbated by the physical assessments in this study.
- More than twice per week of regular and structured resistance training (lifting weights).
- Competed in resistance exercise-related competitions in the past 6 months.
- Taking long-term prescribed medications (including traditional Chinese medicine and other alternative medicine), drugs, steroids, or hormones that can affect any of the measurements in this study.
- Have electrical implant (such as pacemaker, implantable cardioverter defibrillator or neurostimulator), metal or plastic implant/rod/plate, or joint replacement in the body as these objects can affect the accuracy of the body composition measurement.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Abstain from any physical activity except activities of daily living for at least 48 hours.
- Abstain from alcohol and caffeine for at least 24 hours.
- Fast (i.e., do not eat or drink except plain water) overnight for 10 hours. In consideration of the fasting, these sessions will take place in the morning. To control for diurnal variation, the sessions will be timed such that the same measurements will be taken at approximately the same time of the day (+/- 1 hour difference).
- Obtain a full night of sleep the night before.
Session 1
- Read and sign consent form
- Pre-screening:
- Subject screening questionnaire
- Global Physical Activity Questionnaire
- Body mass
- Height
- Resting blood pressure and heart rate
- Fasting blood glucose (via finger prick)
Session 2 The 4-week alternate-day fasting programme will start within 14 days from session 1
- Collection of 4 weeks of supplements
- Body mass
- Height
- Resting blood pressure and heart rate
- Fasting blood glucose (via finger prick)
- Waist and hip circumference measurements
- Body composition using bioelectrical impedance analysis and dual-energy X-ray absorptiometry
- Handgrip strength test
- Gait speed test
- Short physical performance battery
- Complete questionnaires on food craving, mood, appetite, hunger, satiety, diet satisfaction, and cognitive function
- Blood sample from forearm (35 ml)
Session 3 28 days (4 weeks) after the start of alternate-day fasting
- Same as session 2 except collection of supplements (not applicable)
- Conditions
- Overweight and Obese Adults, BMI>=23 kg/m2
- Being tested
- Placebo, Protein, Leucine
- Keywords
- Overweight, Obese, Intermittent Fasting, Alternate Day Fasting, Protein, Leucine, Skeletal muscle, muscle, blood health, mood, appetite, food craving
- Medical subject headings
- Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Control (placebo supplements) 0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal
ProteinDietary supplement
Protein supplements: 0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal
LeucineDietary supplement
Leucine supplementation: 0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal Receives: Dietary Supplement: Placebo |
| Protein | Experimental | 0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal Receives: Dietary Supplement: Protein |
| Leucine | Experimental | 0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal Receives: Dietary Supplement: Leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass
Measured: Start and end of 4-week intervention
Lean Mass
Measured: Start and end of 4-week intervention
Appendicular Lean Mass
Sum of lean mass in upper and lower limbs
Measured: Start and end of 4-week intervention
Body mass index
body mass in kilograms divided by square of height in metres
Measured: Start and end of 4-week intervention
Lean mass index
lean mass in kilograms divided by square of height in metres
Measured: Start and end of 4-week intervention
Appendicular lean mass index
Appendicular lean mass in kilograms divided by square of height in metres
Measured: Start and end of 4-week intervention
Fat mass
Measured: Start and end of 4-week intervention
Percentage body fat
Measured: Start and end of 4-week intervention
Fat mass index
Fat mass in kilograms divided by square of height in metres
Measured: Start and end of 4-week intervention
Trunk fat
Fat mass around the trunk
Measured: Start and end of 4-week intervention
Appendicular fat mass
Sum of fat mass in the upper and lower limbs
Measured: Start and end of 4-week intervention
Appendicular fat mass index
Appendicular fat mass in kilograms divided by square of height in metres
Measured: Start and end of 4-week intervention
Resting systolic blood pressure
Measured: Start and end of 4-week intervention
Resting diastolic blood pressure
Measured: Start and end of 4-week intervention
Fasting blood glucose
Measured: Start and end of 4-week intervention
HbA1c
Measured: Start and end of 4-week intervention
Insulin
Measured: Start and end of 4-week intervention
HOMA-IR
Measured: Start and end of 4-week intervention
Total cholesterol
Measured: Start and end of 4-week intervention
HDL cholesterol
Measured: Start and end of 4-week intervention
LDL cholesterol
Measured: Start and end of 4-week intervention
Total cholesterol to HDL cholesterol ration
Measured: Start and end of 4-week intervention
Triglycerides
Measured: Start and end of 4-week intervention
Secondary outcomes (30)
Android fat
fat around stomach
Measured: Start and end of 4-week intervention
Gynoid fat
fat around hips and mid section
Measured: Start and end of 4-week intervention
Bone mineral content
Measured: Start and end of 4-week intervention
bone mineral density
Measured: Start and end of 4-week intervention
Waist Circumference
Measured: Start and end of 4-week intervention
Hip circumference
Measured: Start and end of 4-week intervention
Waist-to-hip ratio
Measured: Start and end of 4-week intervention
Fat free mass
Fat free mass measured using BIA
Measured: Start and end of 4-week intervention
Skeletal muscle mass
Skeletal muscle mass measured using BIA
Measured: Start and end of 4-week intervention
Appendicular fat-free mass
Sum of fat free mass in upper and lower limbs measured using BIA
Measured: Start and end of 4-week intervention
Visceral fat area
Visceral fat area measured using BIA
Measured: Start and end of 4-week intervention
Fat-free mass index
Fat-free mass in kilograms divided by square of height in metres
Measured: Start and end of 4-week intervention
Skeletal muscle mass index
Skeletal muscle mass in kilograms divided by square of height in metres
Measured: 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
Measured: Start and end of 4-week intervention
Insulin growth factor-1
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Start and end of 4-week intervention
Handgrip strength
Measurement of handgrip strength using a handheld dynamometer
Measured: Start and end of 4-week intervention
Short physical performance battery
Standardised physical performance test
Measured: Start and end of 4-week intervention
6m gait speed
Gait speed over 6m
Measured: Start and end of 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start14 Nov 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, double-blind, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781410
- Sponsor's protocol ID
- IRB-2022-090
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Leucine on Muscle Preservation During Weight Loss in Older Men
- ClinicalTrials.gov ID
- NCT07781410
- Acronym / sponsor ID
- IRB-2022-090
- Conditions
- Overweight and Obese Adults, BMI>=23 kg/m2
- Keywords
- Overweight, Obese, Intermittent Fasting, Alternate Day Fasting, Protein, Leucine, Skeletal muscle, muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Abstain from any physical activity except activities of daily living for at least 48 hours.
- Abstain from alcohol and caffeine for at least 24 hours.
- Fast (i.e., do not eat or drink except plain water) overnight for 10 hours. In consideration of the fasting, these sessions will take place in the morning. To control for diurnal variation, the sessions will be timed such that the same measurements will be taken at approximately the same time of the day (+/- 1 hour difference).
- Obtain a full night of sleep the night before.
Session 1
- Read and sign consent form
- Pre-screening:
- Subject screening questionnaire
- Global Physical Activity Questionnaire
- Body mass
- Height
- Resting blood pressure and heart rate
- Fasting blood glucose (via finger prick)
Session 2 The 4-week alternate-day fasting programme will start within 14 days from session 1
- Collection of 4 weeks of supplements
- Body mass
- Height
- Resting blood pressure and heart rate
- Fasting blood glucose (via finger prick)
- Waist and hip circumference measurements
- Body composition using bioelectrical impedance analysis and dual-energy X-ray absorptiometry
- Handgrip strength test
- Gait speed test
- Short physical performance battery
- Complete questionnaires on food craving, mood, appetite, hunger, satiety, diet satisfaction, and cognitive function
- Blood sample from forearm (35 ml)
Session 3 28 days (4 weeks) after the start of alternate-day fasting
- Same as session 2 except collection of supplements (not applicable)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebo0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal |
| Protein | Experimental | Dietary Supplement: Protein0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal |
| Leucine | Experimental | Dietary Supplement: Leucine0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Of Asian descent
- 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) ≥ 23 kg/m2
Key exclusion criteria (14 listed)
- Unable to adhere to the requirements regarding physical activity and diet as stated in the research methodologies. All supplements; including but not limited to vitamins, minerals, amino acids and proteins; which are not provided by this research, and traditional Chinese medicine are not allowed.
- Vegetarians or vegans due to potential differences in responses and that the supplements provided may contain dairy products.
- Allergic or intolerant to milk. The supplement that you will be required to consume may contain milk proteins, and lactose (milk sugar).
- Failed an exercise stress test.
- Have any health condition(s) that would be made worse by fasting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboControl (placebo supplements) 0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal | Dietary supplement | Control |
| ProteinProtein supplements: 0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal | Dietary supplement | Protein |
| LeucineLeucine supplementation: 0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal | Dietary supplement | Leucine |
Primary outcome
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
Time frame: Start and end of 4-week intervention
Sum of lean mass in upper and lower limbs
Body mass index
Time frame: Start and end of 4-week intervention
body mass in kilograms divided by square of height in metres
Lean mass index
Time frame: Start and end of 4-week intervention
lean mass in kilograms divided by square of height in metres
Appendicular lean mass index
Time frame: Start and end of 4-week intervention
Appendicular lean mass in kilograms divided by square of height in metres
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
Time frame: Start and end of 4-week intervention
Fat mass in kilograms divided by square of height in metres
Trunk fat
Time frame: Start and end of 4-week intervention
Fat mass around the trunk
Appendicular fat mass
Time frame: Start and end of 4-week intervention
Sum of fat mass in the upper and lower limbs
Appendicular fat mass index
Time frame: Start and end of 4-week intervention
Appendicular fat mass in kilograms divided by square of height in metres
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
30 secondary outcomes
Android fat
Time frame: Start and end of 4-week intervention
Gynoid fat
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
Time frame: Start and end of 4-week intervention
Skeletal muscle mass
Time frame: Start and end of 4-week intervention
Appendicular fat-free mass
Time frame: Start and end of 4-week intervention
Visceral fat area
Time frame: Start and end of 4-week intervention
Fat-free mass index
Time frame: Start and end of 4-week intervention
Skeletal muscle mass index
Time frame: Start and end of 4-week intervention
Appendicular fat-free mass index
Time frame: Start and end of 4-week intervention
Insulin growth factor-1
Time frame: Start and end of 4-week intervention
Mood
Time frame: Start and end of 4-week intervention
Food craving - habitual
Time frame: Start and end of 4-week intervention
Food craving - specific foods
Time frame: Start and end of 4-week intervention
Eating Behaviour
Time frame: Start and end of 4-week intervention
Hunger over past 4 weeks
Time frame: Start and end of 4-week intervention
Baseline appetite
Time frame: Start and end of 4-week intervention upon arrival in the laboratory
Satiety over past 4 weeks
Time frame: Start and end of 4-week intervention
Diet satisfaction over past 4 weeks
Time frame: Start and end of 4-week intervention
Implicit satiety goal
Time frame: Start and end of 4-week intervention
Ideal portion size
Time frame: Start and end of 4-week intervention
Expected satiety
Time frame: Start and end of 4-week intervention
Food-related characteristics
Time frame: Start and end of 4-week intervention
Handgrip strength
Time frame: Start and end of 4-week intervention
Short physical performance battery
Time frame: Start and end of 4-week intervention
6m gait speed
Time frame: Start and end of 4-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and Leucine in people with Overweight and Obese Adults and BMI>=23 kg/m2, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass (time frame: Start and end of 4-week intervention). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.