Dose Response of Leucine on Muscle Maintenance During Weight Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Body mass
Study Overview
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 hours in duration. During fasting days, participants abstain from all food and beverages except for ad libitum plain water and other zero-calorie beverages, and a small meal amounting to 25% of daily caloric need. This small meal must be consumed between 12 pm and 2 pm in this study, for standardization to ensure consistency in the total duration of fasting and feeding. During feeding days, participants eat up to approximately 125% of daily caloric need (calculated weekly), with no restriction on meal timing as long as meals are consumed within the 24-hour period. The programme ends after 4 weeks (28 days) of continuous ADF
All food for the 4-week ADF will be provided. 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.
Detailed Description
Participation in this study requires a total of 4 weeks of ADF and 6 laboratory visits (sessions) spread over 5-6 weeks.
To participate in this study, participants will have to:
- complete the questionnaires regarding their health and diet and physical activity level (Global Physical Activity Questionnaire) on session 1,
- complete 5 weekly measurements of resting blood pressure and heart rate, fasting blood glucose (via finger prick blood sample), body mass, height, waist and hip circumferences, and body composition using bioelectrical impedance analysis (BIA) on sessions 1 and 3-6,
- complete the questionnaires regarding their mood [Brunel Mood Scale (BRUMS)], stress [Perceived Stress Scale (PSS)], food craving for general and specific foods [Food Craving Questionnaire-Trait Reduced (FCQ-T-r), and Food Craving Inventory (FCI)], eating behaviour [Three-Factor Eating Questionnaire-R18 - cognitive restraint component (TFEQ-r18)], and appetite, hunger, satiety and diet satisfaction (visual analogue scales, questionnaire and computerised test) twice on sessions 1 and 6,
- provide blood samples twice on sessions 1 and 6 for various biomarkers,
- complete 2 occasions of body composition measurement using dual-energy X-ray absorptiometry (DXA) on sessions 1 and 6,
- complete 4 weeks of ADF as instructed (details given below),
- consume only the food provided (high protein diet with leucine supplement) except for ad libitum intake of plain water and zero caloric beverages during the 4 weeks of ADF,
- complete daily log of food intake (including leftover/unconsumed food), physical activity and sleep during the entire 4 weeks of ADF,
- maintain a consistent diet between session 1 and the start of ADF,
- maintain a consistent physical activity level throughout the entire study. Do not start a new exercise programme during the entire duration of the study, and
- abstain from high level of physical activity throughout the entire study.
Prior to each session except session 2, participants are also 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •21 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
Exclusion Criteria
- •Unable to adhere to the requirements regarding physical activity and diet as stated in the research methodologies.
- •Allergic or intolerant to milk and soy.
- •Any other food allergies or dietary restrictions/preferences that the research team is unable to cater to due to constraints in food preparation and choices in order to control for composition of macronutrients, leucine content and calories in the food provided.
- •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 sugar and blood pressure), lung (except controlled asthma), liver, kidney or joint condition(s).
- •Taking other prescribed medication (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.
Arms & Interventions
0.08g/kg body mass per meal
In this study, participants would be randomly (by chance) assigned 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.
Intervention: leucine (Dietary Supplement)
0.06g/kg body mass per meal
In this study, participants would be randomly (by chance) assigned 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.
Intervention: leucine (Dietary Supplement)
0.02g/kg body mass per meal
In this study, participants would be randomly (by chance) assigned 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.
Intervention: leucine (Dietary Supplement)
0.04g/kg body mass per meal
In this study, participants would be randomly (by chance) assigned 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.
Intervention: leucine (Dietary Supplement)
Outcomes
Primary Outcomes
Body mass
Time Frame: Start and end of 4-week intervention and weekly during intervention
Body mass
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 and weekly during intervention
Resting diastolic blood pressure
Time Frame: Start and end of 4-week intervention and weekly during intervention
Fasting blood glucose
Time Frame: Start and end of 4-week intervention and weekly during intervention
HbA1c
Time Frame: Start and end of 4-week intervention
Total cholesterol to HDL cholesterol ratio
Time Frame: Start and end of 4-week intervention
Insulin
Time Frame: Start and end of 4-week intervention
LDL cholesterol
Time Frame: Start and end of 4-week intervention
Lean mass
Time Frame: Start and end of 4-week intervention
Lean mass measured using DXA
Appendicular Lean Mass
Time Frame: Start and end of 4-week intervention
Sum of lean mass in upper and lower limbs measured using DXA
Body mass index
Time Frame: Start and end of 4-week intervention and weekly during intervention
body mass in kilograms divided by sqaure 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 and weekly during intervention
Fat mass
Percentage body fat
Time Frame: Start and end of 4-week intervention and weekly during intervention
Percentage body fat
Fat mass index
Time Frame: Start and end of 4-week intervention and weekly during 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
The HOMA-IR index
Time Frame: Start and end of 4-week intervention
Homeostatic Model Assessment of Insulin Resistance index
Total cholesterol
Time Frame: Start and end of 4-week intervention
HDL cholesterol
Time Frame: Start and end of 4-week intervention
Triglycerides
Time Frame: Start and end of 4-week intervention
Secondary Outcomes
- Appendicular fat-free mass index(Start and end of 4-week intervention and weekly during intervention)
- Insulin growth factor-1(Time Frame: Start and end of 4-week intervention)
- Gynoid fat mass(Start and end of 4-week intervention)
- Android fat mass(Start and end of 4-week intervention)
- Bone mineral content(Start and end of 4-week intervention)
- Bone mineral density(Start and end of 4-week intervention)
- Waist Circumference(Start and end of 4-week intervention and weekly during intervention)
- Hip circumference(Start and end of 4-week intervention and weekly during intervention)
- Waist-to-hip ratio(Start and end of 4-week intervention and weekly during intervention)
- Fat free mass(Start and end of 4-week intervention and weekly during intervention)
- Skeletal muscle mass(Start and end of 4-week intervention and weekly during intervention)
- Appendicular fat-free mass(Start and end of 4-week intervention and weekly during intervention)
- Visceral fat area(Start and end of 4-week intervention and weekly during intervention)
- Fat-free mass index(Start and end of 4-week intervention and weekly during intervention)
- Skeletal muscle mass index(Start and end of 4-week intervention and weekly during intervention)
- Mood(Start and end of 4-week intervention)
- Stress level(Start and end of 4-week intervention)
- Food craving - habitual(Start and end of 4-week intervention)
- Food craving - specific foods(Start and end of 4-week intervention)
- Eating Behaviour(Start and end of 4-week intervention)
- Baseline appetite(Start and end of 4-week intervention upon arrival in the laboratory)
- Hunger over past 4 weeks(Start (i.e. over the past 4 weeks before start of the intervention) and end of 4-week intervention (i.e. over the past 4 weeks during the intervention))
- Satiety over past 4 weeks(Start (i.e. over the past 4 weeks before start of the intervention) and end of 4-week intervention (i.e. over the past 4 weeks during the intervention))
- Diet satisfaction over past 4 weeks(Start (i.e. over the past 4 weeks before start of the intervention) and end of 4-week intervention (i.e. over the past 4 weeks during the intervention))
- Implicit satiety goal(Start and end of 4-week intervention)
- Ideal portion size(Start and end of 4-week intervention)
- Expected satiety(Start and end of 4-week intervention)
- Food-related characteristics(Start and end of 4-week intervention)