Loading
BMI >= 23 / leucine / Overweight and Obese Adults · Interventional Study
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed, registry-only record of a randomized, double-blind dose-response study of leucine (four doses: 0.02, 0.04, 0.06, 0.08 g/kg body mass per meal) during 4-week alternate-day fasting in 92 overweight and obese young men (BMI ≥23). No results have been posted to the registry; the study measures body composition, lean mass, and metabolic parameters as primary outcomes, but the actual effects of leucine dose on muscle maintenance remain unreported.
Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Overweight and Obese Adults, BMI >= 23; Male; age from 21 Years; to 35 Years. Intervention: 0.02g/kg body mass per meal/day; 0.04g/kg body mass per meal/day; 0.06g/kg body mass per meal/day; 0.08g/kg body mass per meal/day. Compared with: Dose-response comparison across four leucine dose levels (no explicit zero-leucine control reported).. n = 92. 1 site: Singapore.
This is a completed, registry-only record of a randomized, double-blind dose-response study of leucine (four doses: 0.02, 0.04, 0.06, 0.08 g/kg body mass per meal) during 4-week alternate-day fasting in 92 overweight and obese young men (BMI ≥23). No results have been posted to the registry; the study measures body composition, lean mass, and metabolic parameters as primary outcomes, but the actual effects of leucine dose on muscle maintenance remain unreported.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The clinical implications of leucine dose on muscle retention during alternate-day fasting in this population cannot be assessed from this registry record alone. Results are needed to determine whether leucine supplementation offers a clinically meaningful benefit for muscle preservation during weight loss in young overweight men.
This is a completed registry record for a small interventional study with surrogate endpoints (body composition) in a narrow population, testing dose-response; results are not yet reported, so the evidence strength cannot be assessed.
As stated by the source record.
Quoted from the source exactly as published.
The clinical implications of leucine dose on muscle retention during alternate-day fasting in this population cannot be assessed from this registry record alone. Results are needed to determine whether leucine supplementation offers a clinically meaningful benefit for muscle preservation during weight loss in young overweight men.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07583875). This is a study registration, not published results. Lead sponsor: Nanyang Technological University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 92 participants (ACTUAL). Conditions: Overweight and Obese Adults, BMI >= 23. Interventions: DIETARY_SUPPLEMENT: leucine; DIETARY_SUPPLEMENT: leucine; DIETARY_SUPPLEMENT: leucine; DIETARY_SUPPLEMENT: leucine. Primary outcome measures: Body mass , Start and end of 4-week intervention and weekly during intervention; Lean mass , Start and end of 4-week intervention; Appendicular Lean Mass , Start and end of 4-week intervention; Body mass index , Start and end of 4-week intervention and weekly during intervention; Lean mass index , Start and end of 4-week intervention; Appendicular lean mass index , Start and end of 4-week intervention; Fat mass , Start and end of 4-week intervention and weekly during intervention; Percentage body fat , Start and end of 4-week intervention and weekly during intervention; Fat mass index , Start and end of 4-week intervention and weekly during intervention; Trunk fat , Start and end of 4-week intervention; Appendicular fat mass , Start and end of 4-week intervention; Appendicular fat-free mass index , Start and end of 4-week intervention and weekly during intervention; Resting systolic blood pressure , Start and end of 4-week intervention and weekly during intervention; Resting diastolic blood pressure , Start and end of 4-week intervention and weekly during intervention; Fasting blood glucose , Start and end of 4-week intervention and weekly during intervention; HbA1c , Start and end of 4-week intervention; Insulin , Start and end of 4-week intervention; The HOMA-IR index , Start and end of 4-week intervention; Total cholesterol , Start and end of 4-week intervention; HDL cholesterol , Start and end of 4-week intervention; LDL cholesterol , Start and end of 4-week intervention; Total cholesterol to HDL cholesterol ratio , Start and end of 4-week intervention; Triglycerides , Start and end of 4-week intervention. Brief summary: The objective of this research is to determine if there is dose response of leucine on muscle maintenance during 4-week of alternate-day fasting (ADF) on blood parameters, body composition, mood and parameters related to appetite in young men with a body mass index of 23kg/m2 and above, whose body mass falls outside of the healthy range for their height (Asian reference point for increased risk of cardiovascular diseases). Participants have no diagnoses of, and are not prescribed medications for, cardiovascular, metabolic, diabetic, lung (except controlled asthma), kidney, or joint health conditions. To achieve this objective, 100 hundred young men, aged between 21 and 35 years old will be recruited to 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. During the fasting days, participants will abstain from all food and beverages except for ad libitum intake of plain water and other zero caloric beverages, and a small meal that is 25% of daily caloric need. This small meal must be consumed during 12 pm to 2 pm in this study for standardisation to ensure consistency in total duration of fasting and feeding. During the feeding days, participants will eat up to \~125% of daily caloric need (calculated every week) with no restriction on the timing of meals as long as they are within the 24-hour period. The programme will end after 4 weeks (28 days) of continuous ADF. All food for the 4-week ADF will be provided. Protein intake will be up to \~1.2 g/kg body mass/day on fasting day and up to \~2.4 g/kg body mass/day (\~32-40% of calories) on feeding days. Participants will be randomly assigned (double blind) to the amount of leucine in their diet: 0.02, 0.04, 0.06 or 0.08 g/kg body mass per meal for 1 meal/day on fasting days and 3 meals/day on feeding days. Blood parameters, body mass, height, waist-to-hip ratio, body composition, mood, stress level, and parameters related to eating and appetite will be measured before and after 4-week of ADF. The investigators hypothesised a dose response in leucine to maintain muscle mass during weight loss.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.