Dose Response of Leucine on Muscle Maintenance During Weight Loss
maanantai 17. elokuuta 2026 päivittänyt: Nanyang Technological University
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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
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
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
92
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
-
Singapore, Singapore, 637616
- Nanyang Technological University
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
0.02g/kg body mass/meal
0.04g/kg body mass/meal
0.06g/kg body mass/meal
0.08g/kg body mass/meal
|
|
Kokeellinen: 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.
|
0.02g/kg body mass/meal
0.04g/kg body mass/meal
0.06g/kg body mass/meal
0.08g/kg body mass/meal
|
|
Kokeellinen: 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.
|
0.02g/kg body mass/meal
0.04g/kg body mass/meal
0.06g/kg body mass/meal
0.08g/kg body mass/meal
|
|
Kokeellinen: 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.
|
0.02g/kg body mass/meal
0.04g/kg body mass/meal
0.06g/kg body mass/meal
0.08g/kg body mass/meal
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Lean mass
Aikaikkuna: Start and end of 4-week intervention
|
Lean mass measured using DXA
|
Start and end of 4-week intervention
|
|
Appendicular Lean Mass
Aikaikkuna: Start and end of 4-week intervention
|
Sum of lean mass in upper and lower limbs measured using DXA
|
Start and end of 4-week intervention
|
|
Body mass index
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
body mass in kilograms divided by sqaure of height in metres
|
Start and end of 4-week intervention and weekly during intervention
|
|
Lean mass index
Aikaikkuna: Start and end of 4-week intervention
|
lean mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention
|
|
Appendicular lean mass index
Aikaikkuna: Start and end of 4-week intervention
|
Appendicular lean mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention
|
|
Fat mass
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Fat mass
|
Start and end of 4-week intervention and weekly during intervention
|
|
Percentage body fat
Aikaikkuna: 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
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Fat mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention and weekly during intervention
|
|
Trunk fat
Aikaikkuna: Start and end of 4-week intervention
|
Fat mass around the trunk
|
Start and end of 4-week intervention
|
|
Appendicular fat mass
Aikaikkuna: Start and end of 4-week intervention
|
Sum of fat mass in the upper and lower limbs
|
Start and end of 4-week intervention
|
|
Resting systolic blood pressure
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Start and end of 4-week intervention and weekly during intervention
|
|
|
Resting diastolic blood pressure
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Start and end of 4-week intervention and weekly during intervention
|
|
|
Fasting blood glucose
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Start and end of 4-week intervention and weekly during intervention
|
|
|
HbA1c
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Insulin
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
The HOMA-IR index
Aikaikkuna: Start and end of 4-week intervention
|
Homeostatic Model Assessment of Insulin Resistance index
|
Start and end of 4-week intervention
|
|
Total cholesterol
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
HDL cholesterol
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
LDL cholesterol
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Total cholesterol to HDL cholesterol ratio
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Triglycerides
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Body mass
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Body mass
|
Start and end of 4-week intervention and weekly during intervention
|
|
Appendicular fat mass index
Aikaikkuna: Start and end of 4-week intervention
|
Appendicular fat mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Appendicular fat-free mass index
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Appendicular fat-free mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention and weekly during intervention
|
|
Android fat mass
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Gynoid fat mass
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Bone mineral content
Aikaikkuna: Start and end of 4-week intervention
|
Bone mass
|
Start and end of 4-week intervention
|
|
Bone mineral density
Aikaikkuna: Start and end of 4-week intervention
|
Bone mineral density
|
Start and end of 4-week intervention
|
|
Waist Circumference
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Waist Circumference
|
Start and end of 4-week intervention and weekly during intervention
|
|
Hip circumference
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Start and end of 4-week intervention and weekly during intervention
|
|
|
Waist-to-hip ratio
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Waist circumference to hip circumference ratio
|
Start and end of 4-week intervention and weekly during intervention
|
|
Fat free mass
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Fat free mass measured using BIA
|
Start and end of 4-week intervention and weekly during intervention
|
|
Skeletal muscle mass
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Skeletal muscle mass measured using BIA
|
Start and end of 4-week intervention and weekly during intervention
|
|
Appendicular fat-free mass
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Sum of fat free mass in upper and lower limbs measured using BIA
|
Start and end of 4-week intervention and weekly during intervention
|
|
Visceral fat area
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Visceral fat area measured using BIA
|
Start and end of 4-week intervention and weekly during intervention
|
|
Fat-free mass index
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Fat-free mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention and weekly during intervention
|
|
Skeletal muscle mass index
Aikaikkuna: Start and end of 4-week intervention and weekly during intervention
|
Skeletal muscle mass in kilograms divided by square of height in metres
|
Start and end of 4-week intervention and weekly during intervention
|
|
Mood
Aikaikkuna: 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).
|
Start and end of 4-week intervention
|
|
Stress level
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Food craving - habitual
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Food craving - specific foods
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Eating Behaviour
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Baseline appetite
Aikaikkuna: 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
|
Start and end of 4-week intervention upon arrival in the laboratory
|
|
Hunger over past 4 weeks
Aikaikkuna: 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.
|
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
Aikaikkuna: 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.
|
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
Aikaikkuna: 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.
|
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
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Ideal portion size
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Expected satiety
Aikaikkuna: 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).
|
Start and end of 4-week intervention
|
|
Food-related characteristics
Aikaikkuna: 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.
|
Start and end of 4-week intervention
|
|
Insulin growth factor-1
Aikaikkuna: Time Frame: Start and end of 4-week intervention
|
Time Frame: Start and end of 4-week intervention
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Height
Aikaikkuna: Start and end of 4-week intervention and weekly
|
Height - used to calculate body mass index and other indices
|
Start and end of 4-week intervention and weekly
|
|
Hydration status
Aikaikkuna: Start and end of 4-week intervention and weekly during 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.
|
Start and end of 4-week intervention and weekly during intervention
|
|
SGP/ALT
Aikaikkuna: Start and end of 4-week intervention
|
blood biomarker of liver function
|
Start and end of 4-week intervention
|
|
SGOT/AST
Aikaikkuna: Start and end of 4-week intervention
|
blood biomarker of liver function
|
Start and end of 4-week intervention
|
|
Serum sodium
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Serum potassium
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Serum urea
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Serum creatinine
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Full blood count
Aikaikkuna: Start and end of 4-week intervention
|
Start and end of 4-week intervention
|
|
|
Weekly physical activity level
Aikaikkuna: 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.
|
1-2 weeks before the start of the intervention and for each week of the 4-week intervention
|
|
Food diary
Aikaikkuna: Daily during the 4-week intervention
|
Participants have to record daily whether they finish the food provided, including the portion of leftovers if any.
On fasting days, they also log the timing of their small meal
|
Daily during the 4-week intervention
|
|
Sleep diary
Aikaikkuna: Daily during the 4-week intervention
|
Participants have to log their sleep time, wake up time and subjective sleep quality daily
|
Daily during the 4-week intervention
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Ensimmäinen lähetetty
Sunnuntai 26. huhtikuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 6. toukokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 13. toukokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 18. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 17. elokuuta 2026
Viimeksi vahvistettu
Keskiviikko 1. huhtikuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Ravitsemushäiriöt
- Yliravitsemus
- Kehon paino
- Patologiset tilat, merkit ja oireet
- Käyttäytyminen
- Ravitsemukselliset ja aineenvaihduntataudit
- Merkit ja oireet
- Ruokintakäyttäytyminen
- Paasto
- Ylipainoinen
- Lihavuus
- Ajoittainen paasto
- Aminohapot, peptidit ja proteiinit
- Aminohapot
- Välttämättömät aminohapot
- Aminohapot, haarautuneen ketju
- Leusiini
Muut tutkimustunnusnumerot
- IRB 2019-07-039
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
IPD sharing will be available upon request.
IPD-jaon käyttöoikeuskriteerit
Individual participant data (IPD) will be made available to qualified researchers upon request.
To access the data, researchers must submit a formal request, which will be reviewed and approved by the data sharing committee.
Data access will be granted for research purposes only and will require adherence to data use agreements and ethics guidelines.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .