HealthyMONWNCT06802341
Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight Individuals
A study testing Normal protein diet, Animal protein diet and Plant based diet in people with Healthy and Glucose Metabolism Disorders, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
Asians tend to develop type 2 diabetes (T2D) at lower body mass index (BMI) levels and younger ages compared to other populations. This leads to a longer duration of suffering from long-term complications associated with the disease, ultimately resulting in shorter life expectancy. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Glucose Metabolism Disorders, Obesity, Visceral
- What is being tested?
- Normal protein diet, Animal protein diet and Plant based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2022to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.5 - 24.9 kg/m2
- Non-diabetic
- Blood pressure (≤140/90 mmHg)
- <5% weight change in the past 6 months
- Fasting triglyceride < 90 mg/dl and HOMA-IR ≤ 1.0 will be defined as healthy subjects
- Fasting triglyceride ≥ 90 mg/dl and HOMA-IR > 1.0 will be defined as MONW subjects
Who cannot join
- • Smoker or currently on nicotine therapy
- Regularly consume alcohol >1 unit per day
- On hypocaloric/hypercaloric diet aiming for weight loss/gain
- An athlete or sportive person with regular exercising >3 times per week and >45 minutes per section.
- Currently receiving therapy (e.g. insulin) or any medication/ treatment (including supplements) that may affect glucose and lipid metabolism, energy metabolism or body composition
- Currently on steroids, protease inhibitors, or antipsychotics therapies
Show all 20Show fewer
- Has symptomatic Irritable Bowel Syndrome
- Has glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Had major medical or surgical event requiring hospitalization within the preceding 3 months
- Participated in drug trials within 3 months before the start of the study
- Donated blood within 3 months before the start of the study
- Has intolerances or allergies to any of the study foods (eg. anaphylaxis to glutens)
- Pregnant (pregnancy test will be done), lactating, or planning to be become pregnant during the study period
- Has active Tuberculosis (TB) or currently receiving treatment for TB
- Has chronic infection or is known to suffer from or has previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Has claustrophobia, trypanophobia, or hemophobia
- Unwilling to consume study foods
- Inadequate fluency in the English language
- Unable to understand the study procedures and signs forms providing written informed consent to participate in the study.
- Is a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
About this study
Official title: Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight (MONW) Individuals
Asians tend to develop type 2 diabetes (T2D) at lower body mass index (BMI) levels and younger ages compared to other populations. This leads to a longer duration of suffering from long-term complications associated with the disease, ultimately resulting in shorter life expectancy. Notably, approximately 40% of newly diagnosed T2D cases in Asians occur in individuals considered lean, with a BMI reported to be less than 22 kg/m2. This phenomenon is termed the "Metabolically Obese Normal Weight" (MONW) phenotype. MONW individuals are characterized as having a normal body weight but exhibiting obesity-related metabolic disturbances, including excess body fat with ectopic fat deposition, insulin resistance, and dyslipidemia.
Read the detailed description
Asian populations have higher prevalence of abdominal obesity, accounting for ~60% of the global diabetic population. Type 2 diabetes (T2D) developing at lower BMI levels and younger ages compared to Western populations, suggest underlying metabolic issues in Asian. A cluster of metabolically obese, normal weight (MONW) individuals are identified in 40% of newly diagnosed Asian T2D.
MONW individuals have normal body weight but exhibit obesity-related metabolic disturbances, such as excess body fat, insulin resistance, and dyslipidemia, predisposing them to develop metabolic symptoms such as T2D and cardiovascular disease. They also show reduced physical activity, lower aerobic capacity, low muscle quality and impaired thermogenesis. Elevated plasma amino acids are associated with insulin resistance, resembling obesity, diabetes and sarcopenia. Given the complex nature of MONW, further examination is needed for early diagnosis and effective prevention strategies. Increased protein intake is known to improve satiety, thermogenesis and muscle health, while enhancing insulin sensitivity and fat oxidation. High-protein diets can aid in weight loss and are often preferred over traditional calorie restriction for combating obesity. In our previous study, a 5% weight loss from calorie restriction improved body composition and metabolism in MONW individuals. Hence, this study aims to 1) better understand the physiology and energy balance of MONW individuals; 2) identify biomarkers for early diagnosis; and 3) examine the effects of high-protein diets on the metabolism of MONW individuals. The study will involve participants of Chinese descent, evaluating metabolic biomarkers in energy balance and the impact of different protein sources on their acute metabolic effects.
- Conditions
- Healthy, Glucose Metabolism Disorders, Obesity, Visceral, Obesity; Endocrine, Insulin Sensitivity, Insulin Resistance
- Being tested
- Normal protein diet, Animal protein diet, Plant based diet
- Keywords
- Glycaemic control
- Medical subject headings
- Glucose Metabolism Disorders, Obesity, Abdominal, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal protein dietOther
Animal-based protein meal plan consisted of 60% carbohydrates, 10% proteins and 30% lipids
Animal protein dietOther
Animal based high protein meal consisting of 40% carbohydrates, 30% proteins and 30% lipids
Plant based dietOther
Plant based high protein meal consisting of 40% carbohydrates, 30% proteins and 30% lipids
| Study group | Role | What they receive |
|---|---|---|
| Normal protein diet | Experimental | Animal based protein. 60% carbohydrates, 10% proteins and 30% lipids (i.e. 0.8g of protein/kg of body weight/day) Receives: Other: Normal protein diet |
| Animal based high protein meal | Experimental | 40% carbohydrates, 30% proteins and 30% lipids (i.e. 2.4g of protein/kg of body weight/day) Receives: Other: Animal protein diet |
| Plant based high protein meal | Experimental | 40% carbohydrates, 30% proteins and 30% lipids (i.e. 2.4g of protein/kg of body weight/day) Receives: Other: Plant based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gycaemic control
The primary outcome in this study is the effect on glycaemic control (fasting glucose, insulin, insulin sensitivity).
Measured: Blood will be sampled at timepoints, t = 0minute(fasting), following the meal test,for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes),and pre- and post-exercise
Energy expenditure and fuel utilization
Metabolism will be assessed in the whole body calorimeter (WBC). Only one subject alone in the WBC room during the test. The subject can move around freely. O2 consumption and CO2 production will be detailed energy metabolism in different parameters, such as RMR, DIT, PAEE and NEAT.measured to calculate energy expenditure using Weir formulae Urine samples collected across 4 different sessions throughout the WBC stay to assess protein utilisation
Measured: Assessed for 9 hours in the whole body calorimeter room on visits 3, 4 and 5. 30 minute-RMR,3hour-DIT, 30minute-exercise-induced EE (or PAEE)); urine samples collected on 4 different sessions throughout the WBC
Postprandial amino acids and proteomics profiles
To identify novel biomarkers and gain insights to investigate phenotypic differences of MONW individuals.
Measured: Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t=60 minutes.
Secondary outcomes (4)
Postprandial profiles of lipid and inflammation
Effects on fasting lipids and inflammatory markers
Measured: Blood will be sampled at timepoints, t = 0 minute (fasting), following the meal test, for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes), and pre- and post-exercise.
Measure of appetite regulation and postprandial gut hormones
A visual analogue scale incorporating a 100-point rating scale will be used to assess each appetitive sensation, e.g. hunger, fullness, desire to eat, induced by each intervention. Gut hormones will also be measured from blood samples.
Measured: Rate hunger and satiety immediately before (t=0 minute) and after meal (t=15, 30, 60, 120, 180, and 240 minutes)
Measure of muscle and inflammation biomarkers after exercise bout
Measure of muscle and inflammation biomarkers after exercise to evaluating metabolic biomarkers in energy balance
Measured: Blood samples were taken prior to the exercise and immediately after the 30-minute exercise
Baseline gut microbial populations and functions and relationship to the host's diet
Subjects will be instructed to pass stool onto a provided dry clean stool catcher and transfer 1-5 grams stool specimen using a spatula attached to the tube lid into the stool collection leak prof tube containing preservatives.
Measured: 1 stool sample collected during study,taken at baseline (between baseline visit and before first intervention visit). Can be collected in centre or at home using a stool kit. Kit contained stabilising reagents to stabilize DNA and RNA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802341
- Sponsor's protocol ID
- 2021-192
- Acronym
- MONW
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight (MONW) Individuals
- ClinicalTrials.gov ID
- NCT06802341
- Acronym / sponsor ID
- MONW / 2021-192
- Conditions
- Healthy, Glucose Metabolism Disorders, Obesity, Visceral, Obesity; Endocrine, Insulin Sensitivity, Insulin Resistance
- Keywords
- Glycaemic control
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asians tend to develop type 2 diabetes (T2D) at lower body mass index (BMI) levels and younger ages compared to other populations. This leads to a longer duration of suffering from long-term complications associated with the disease, ultimately resulting in shorter life expectancy. Notably, approximately 40% of newly diagnosed T2D cases in Asians occur in individuals considered lean, with a BMI reported to be less than 22 kg/m2. This phenomenon is termed the "Metabolically Obese Normal Weight" (MONW) phenotype. MONW individuals are characterized as having a normal body weight but exhibiting obesity-related metabolic disturbances, including excess body fat with ectopic fat deposition, insulin resistance, and dyslipidemia.
Detailed description
Asian populations have higher prevalence of abdominal obesity, accounting for ~60% of the global diabetic population. Type 2 diabetes (T2D) developing at lower BMI levels and younger ages compared to Western populations, suggest underlying metabolic issues in Asian. A cluster of metabolically obese, normal weight (MONW) individuals are identified in 40% of newly diagnosed Asian T2D.
MONW individuals have normal body weight but exhibit obesity-related metabolic disturbances, such as excess body fat, insulin resistance, and dyslipidemia, predisposing them to develop metabolic symptoms such as T2D and cardiovascular disease. They also show reduced physical activity, lower aerobic capacity, low muscle quality and impaired thermogenesis. Elevated plasma amino acids are associated with insulin resistance, resembling obesity, diabetes and sarcopenia. Given the complex nature of MONW, further examination is needed for early diagnosis and effective prevention strategies. Increased protein intake is known to improve satiety, thermogenesis and muscle health, while enhancing insulin sensitivity and fat oxidation. High-protein diets can aid in weight loss and are often preferred over traditional calorie restriction for combating obesity. In our previous study, a 5% weight loss from calorie restriction improved body composition and metabolism in MONW individuals. Hence, this study aims to 1) better understand the physiology and energy balance of MONW individuals; 2) identify biomarkers for early diagnosis; and 3) examine the effects of high-protein diets on the metabolism of MONW individuals. The study will involve participants of Chinese descent, evaluating metabolic biomarkers in energy balance and the impact of different protein sources on their acute metabolic effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Normal protein diet | Experimental | Other: Normal protein dietAnimal based protein. 60% carbohydrates, 10% proteins and 30% lipids (i.e. 0.8g of protein/kg of body weight/day) |
| Animal based high protein meal | Experimental | Other: Animal protein diet40% carbohydrates, 30% proteins and 30% lipids (i.e. 2.4g of protein/kg of body weight/day) |
| Plant based high protein meal | Experimental | Other: Plant based diet40% carbohydrates, 30% proteins and 30% lipids (i.e. 2.4g of protein/kg of body weight/day) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index between 18.5 - 24.9 kg/m2
- Non-diabetic
- Blood pressure (≤140/90 mmHg)
- <5% weight change in the past 6 months
- Fasting triglyceride < 90 mg/dl and HOMA-IR ≤ 1.0 will be defined as healthy subjects
Key exclusion criteria (20 listed)
- • Smoker or currently on nicotine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal protein dietAnimal-based protein meal plan consisted of 60% carbohydrates, 10% proteins and 30% lipids | Other | Normal protein diet |
| Animal protein dietAnimal based high protein meal consisting of 40% carbohydrates, 30% proteins and 30% lipids | Other | Animal based high protein meal |
| Plant based dietPlant based high protein meal consisting of 40% carbohydrates, 30% proteins and 30% lipids | Other | Plant based high protein meal |
Primary outcome
Gycaemic control
Time frame: Blood will be sampled at timepoints, t = 0minute(fasting), following the meal test,for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes),and pre- and post-exercise
The primary outcome in this study is the effect on glycaemic control (fasting glucose, insulin, insulin sensitivity).
Energy expenditure and fuel utilization
Time frame: Assessed for 9 hours in the whole body calorimeter room on visits 3, 4 and 5. 30 minute-RMR,3hour-DIT, 30minute-exercise-induced EE (or PAEE)); urine samples collected on 4 different sessions throughout the WBC
Metabolism will be assessed in the whole body calorimeter (WBC). Only one subject alone in the WBC room during the test. The subject can move around freely. O2 consumption and CO2 production will be detailed energy metabolism in different parameters, such as RMR, DIT, PAEE and NEAT.measured to calculate energy expenditure using Weir formulae Urine samples collected across 4 different sessions throughout the WBC stay to assess protein utilisation
Postprandial amino acids and proteomics profiles
Time frame: Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t=60 minutes.
To identify novel biomarkers and gain insights to investigate phenotypic differences of MONW individuals.
4 secondary outcomes
Postprandial profiles of lipid and inflammation
Time frame: Blood will be sampled at timepoints, t = 0 minute (fasting), following the meal test, for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes), and pre- and post-exercise.
Measure of appetite regulation and postprandial gut hormones
Time frame: Rate hunger and satiety immediately before (t=0 minute) and after meal (t=15, 30, 60, 120, 180, and 240 minutes)
Measure of muscle and inflammation biomarkers after exercise bout
Time frame: Blood samples were taken prior to the exercise and immediately after the 30-minute exercise
Baseline gut microbial populations and functions and relationship to the host's diet
Time frame: 1 stool sample collected during study,taken at baseline (between baseline visit and before first intervention visit). Can be collected in centre or at home using a stool kit. Kit contained stabilising reagents to stabilize DNA and RNA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal protein diet, Animal protein diet and Plant based diet in people with Healthy and Glucose Metabolism Disorders, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gycaemic control (time frame: Blood will be sampled at timepoints, t = 0minute(fasting), following the meal test,for 4 hours (t = 15, 30, 60, 90, 120, 150, 180 and 240 minutes),and pre- and post-exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.