BMI >= 23, Overweight and Obese Adults
Conditions
Keywords
Overweight, Obesity, Intermittent fasting, Alternate Day Fasting, ADF, Protein, Leucine, Skeletal muscle, quality weight loss, dose response, muscle maintenance, blood health markers, mood, appetite, food craving
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. The above dietary and physical activity restriction is to minimise the confounding effects of diet and physical activities external to those conducted in this study. Participants will also be instructed to: * Inform the investigators immediately if they fall ill during the study or discover a health condition that requires them to consume any medication, steroids or hormones, and * NOT to take calcium supplements or antacids (e.g. TUMS®) at least 24 hours prior to session 1, and NOT to schedule any scan that involves a contrast agent or ingestion of barium at least 14 days prior to sessions 1 and 6 to ensure accuracy of the DXA scans for body composition. All sessions will be done in a fasted and rested state except session 2. Session 1: • Read and sign consent form * Pre-screening: o Complete questionnaire on health and diet * Resting blood pressure and heart rate * Fasting blood glucose (via finger prick) * Body mass * Height * Complete questionnaires on physical activity level, mood, stress, food craving, eating behaviour, appetite, hunger, satiety and diet satisfaction * Antecubital blood sample * Waist and hip circumference measurements * Body composition using dual-energy X-ray absorptiometry and bioelectrical impedance analysis Session 2: collection of 1 week of food. ADF will start within 10 days from session 1. Body mass and height Session 3: 7 days (1 week) after the start of ADF * Health measurements as in session 1: * Resting blood pressure and heart rate * Fasting blood glucose (via finger prick) * Body mass and height * Waist and hip circumferences * Body composition using bioelectrical impedance analysis * Collection of 1 week of food Session 4: 14 days (2 weeks) after start of fasting programme • Same as session 3 Session 5: 21 days (3 weeks) after start of fasting programme • Same as session 3 Session 6: 28 days (4 weeks) after start of fasting programme • Same as session 1 except consent and pre-screening questionnaires on health and diet, and physical activity level are not applicable
Interventions
DIETARY_SUPPLEMENTleucine
0.02g/kg body mass/meal
Sponsors
Nanyang Technological University
Ministry of Education, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This was a four-arm randomized controlled trial with a double-blind design
Eligibility
Sex/Gender
MALE
Age
21 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Male * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass | Start and end of 4-week intervention and weekly during intervention | Body mass |
| Lean mass | Start and end of 4-week intervention | Lean mass measured using DXA |
| Appendicular Lean Mass | Start and end of 4-week intervention | Sum of lean mass in upper and lower limbs measured using DXA |
| Body mass index | 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 | Start and end of 4-week intervention | lean mass in kilograms divided by square of height in metres |
| Appendicular lean mass index | Start and end of 4-week intervention | Appendicular lean mass in kilograms divided by square of height in metres |
| Fat mass | Start and end of 4-week intervention and weekly during intervention | Fat mass |
| Percentage body fat | Start and end of 4-week intervention and weekly during intervention | Percentage body fat |
| Fat mass index | Start and end of 4-week intervention and weekly during intervention | Fat mass in kilograms divided by square of height in metres |
| Trunk fat | Start and end of 4-week intervention | Fat mass around the trunk |
| Appendicular fat mass | Start and end of 4-week intervention | Sum of fat mass in the upper and lower limbs |
| Appendicular fat mass index | Start and end of 4-week intervention | Appendicular fat mass in kilograms divided by square of height in metres |
| 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 | Homeostatic Model Assessment of Insulin Resistance index |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Android fat mass | Start and end of 4-week intervention | — |
| Gynoid fat mass | Start and end of 4-week intervention | — |
| Bone mineral content | Start and end of 4-week intervention | Bone mass |
| Bone mineral density | Start and end of 4-week intervention | Bone mineral density |
| Waist Circumference | Start and end of 4-week intervention and weekly during intervention | Waist Circumference |
| 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 | Waist circumference to hip circumference ratio |
| Fat free mass | Start and end of 4-week intervention and weekly during intervention | Fat free mass measured using BIA |
| Skeletal muscle mass | Start and end of 4-week intervention and weekly during intervention | Skeletal muscle mass measured using BIA |
| Appendicular fat-free mass | Start and end of 4-week intervention and weekly during intervention | Sum of fat free mass in upper and lower limbs measured using BIA |
| Visceral fat area | Start and end of 4-week intervention and weekly during intervention | Visceral fat area measured using BIA |
| Fat-free mass index | Start and end of 4-week intervention and weekly during intervention | Fat-free mass in kilograms divided by square of height in metres |
| Skeletal muscle mass index | Start and end of 4-week intervention and weekly during intervention | Skeletal muscle mass in kilograms divided by square of height in metres |
| Appendicular fat-free mass index | Start and end of 4-week intervention and weekly during intervention | Appendicular fat-free mass in kilograms divided by square of height in metres |
| Insulin growth factor-1 | Time Frame: Start and end of 4-week intervention | — |
| Mood | Start and end of 4-week intervention | 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). |
| Stress level | Start and end of 4-week intervention | Perceived Stress Scale (PSS). The 10-item PSS asks participants about feelings and thoughts during the last month, with responses ranging from 0 (never) to 4 (very often). The final score obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress. |
| Food craving - habitual | Start and end of 4-week intervention | 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. |
| Food craving - specific foods | Start and end of 4-week intervention | 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. |
| Eating Behaviour | Start and end of 4-week intervention | 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. |
| 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) | Hunger over past 4 weeks. Visual analogue scale 0 to 100. The higher the number the greater the amount of hunger. |
| Baseline appetite | Start and end of 4-week intervention upon arrival in the laboratory | Baseline appetite using visual analogue scale 0 to 100. The higher the score, the higher the baseline appetite |
| 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) | Satiety over past 4 weeks. Visual analogue scale 0 to 100. The higher the number, the greater amount of satiety. |
| 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) | Diet satisfaction over past 4 weeks. Visual analogue scale 0 to 100. The higher the number the greater the satisfaction. |
| Implicit satiety goal | Start and end of 4-week intervention | Implicit 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. |
| Ideal portion size | Start and end of 4-week intervention | 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. |
| Expected satiety | Start and end of 4-week intervention | 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). |
| Food-related characteristics | Start and end of 4-week intervention | 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. |
Countries
Singapore
Outcome results
None listed