Dose Response of Leucine on Muscle Maintenance During Weight Loss

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.

Conditions

• Overweight and Obese Adults
• BMI >= 23

Interventions

DIETARY_SUPPLEMENT

leucine

0.02g/kg body mass/meal/day

DIETARY_SUPPLEMENT

leucine

0.04g/kg body mass/meal/day

DIETARY_SUPPLEMENT

leucine

0.06g/kg body mass/meal/day

DIETARY_SUPPLEMENT

leucine

0.08g/kg body mass/meal/day

Sponsors & Collaborators

• Ministry of Education, Singapore

  collaborator OTHER_GOV

• Nanyang Technological University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-18

Primary Completion

2021-02-11

Completion

2021-02-11

Countries

• Singapore

Study Locations