Nanyang Technological University
Singapore
NCT Number: NCT07781410
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.
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Notify Me60 year and older
Male
Interventional
Not applicable
Singapore
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:
Session 1
Session 2 The 4-week alternate-day fasting programme will start within 14 days from session 1
Session 3 28 days (4 weeks) after the start of alternate-day fasting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(all of the criteria):
Exclusion criteria
(any of the criteria):
Control (placebo supplements) 0.0 g/kg protein and 0.0 g/kg leucine supplementation per meal
Protein supplements: 0.4 g/kg protein and 0.04 g/kg leucine supplementation per meal
Leucine supplementation: 0.0 g/kg protein and 0.08 g/kg leucine supplementation per meal
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Sum of lean mass in upper and lower limbs
Time frame: Start and end of 4-week intervention
body mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
lean mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Appendicular lean mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Fat mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Fat mass around the trunk
Time frame: Start and end of 4-week intervention
Sum of fat mass in the upper and lower limbs
Time frame: Start and end of 4-week intervention
Appendicular fat mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
fat around stomach
Time frame: Start and end of 4-week intervention
fat around hips and mid section
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Fat free mass measured using BIA
Time frame: Start and end of 4-week intervention
Skeletal muscle mass measured using BIA
Time frame: Start and end of 4-week intervention
Sum of fat free mass in upper and lower limbs measured using BIA
Time frame: Start and end of 4-week intervention
Visceral fat area measured using BIA
Time frame: Start and end of 4-week intervention
Fat-free mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Skeletal muscle mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Appendicular fat-free mass in kilograms divided by square of height in metres
Time frame: Start and end of 4-week intervention
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Start and end of 4-week intervention
Hunger over past 4 weeks. Visual analogue scale 0 to 100. The higher the number the greater the amount of hunger.
Time frame: 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
Time frame: Start and end of 4-week intervention
Satiety over past 4 weeks. Visual analogue scale 0 to 100. The higher the number, the greater amount of satiety.
Time frame: Start and end of 4-week intervention
Diet satisfaction over past 4 weeks. Visual analogue scale 0 to 100. The higher the number the greater the satisfaction.
Time frame: Start and end of 4-week intervention
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Start and end of 4-week intervention
Measurement of handgrip strength using a handheld dynamometer
Time frame: Start and end of 4-week intervention
Standardised physical performance test
Time frame: Start and end of 4-week intervention
Gait speed over 6m
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Intracellular water (litre)/extracellular water (litre). This ratio is a reflection of the hydration status in the body. Hydration status can affect the body composition measurements using BIA.
Time frame: Start and end of 4-week intervention
blood biomarker of liver function
Time frame: Start and end of 4-week intervention
blood biomarker of liver function
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: Start and end of 4-week intervention
Time frame: 1-2 weeks before the start of the intervention and for each week of the 4-week intervention
Participants complete the type, intensity and duration of each physical activity during the week similar to Global Physical Activity Questionnaire (GPAQ) developed by the WHO. Each activity is calculated in Metabolic Equivalent (MET) value. Moderate MET value is 4.0 and vigorous MET value is 8.0 while for transport domains MET value is 4.0.
Time frame: 4-day/week during the 4-week intervention
Participants have to record their food intake on 4-day/week
Time frame: Daily during the 4-week intervention
Participants have to log their sleep time, wake up time and subjective sleep quality daily
Nanyang Technological University
Other
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