Overweight and ObesityWLMRNCT05607628
Weight Loss Intervention With Lean Muscle Mass Retention
A study testing Low Calorie Animal Protein Meals and Low Calorie Plant Protein Meals in people with Overweight and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
Overweight and obesity (i.e., excess body fat) is a worldwide health problem, which predisposes individuals to various metabolic diseases. Weight loss through lifestyle modifications such as dietary calorie restrictions and/or exercise are effective approaches to reduce excess body fat. Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Low Calorie Animal Protein Meals and Low Calorie Plant Protein Meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Jul 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Chinese ethnicity
- Age between 40 to 69 years
- Able to give informed consent
- Body Mass Index (BMI) between 23.0 to 32.5 kg/m2
Who cannot join
- Smoking
- Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc
- Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
- Not willing to stop consumption of probiotic or prebiotic supplements within 4 weeks prior to start of study if currently taking these, as well as during study participation
- Not willing to adhere to diet modification as in the study protocol
- Not willing to adhere to the exercise regime as in the study protocol
Show all 26Show fewer
- Taking part in strenuous physical activities
- Not willing to stop any strenuous activity during or within 24 hours of test days (for those actively participating in sports at the competitive and/or endurance levels)
- Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having alcohol consumption on > 4 days per week with ≥ 6 alcoholic drinks per week
- Having sustained elevation of blood pressure (>160/95 mm Hg)
- Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
- Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
- Diabetic
- Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
- Having any prescription medication or any other alternative medicines or supplements which may interfere with study measurements in the in the opinion of the study investigators
- Having antibiotics or suffering from diarrhea within the last 3 months
- Having donated blood within 4 weeks of study participation
- Having poor veins or having history of severe vasovagal syncope (blackouts or fainting) from blood draws
- Having more than 5% weight loss or gain over the past 3 months
- Having metallic implants, pacemaker in the body
- Having claustrophobia
- Having a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain)
- Having severe exercise-induced asthma
- Staff of Wilmar International and/or Singapore Institute of Food and Biotechnology Innovation (SIFBI)
- For female volunteers: menstruation within past 12 months or being on hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Loss Intervention With Lean Muscle Mass Retention (WLMR) Study
Overweight and obesity (i.e., excess body fat) is a worldwide health problem, which predisposes individuals to various metabolic diseases. Weight loss through lifestyle modifications such as dietary calorie restrictions and/or exercise are effective approaches to reduce excess body fat. However, lean muscle mass loss is often an undesired outcome associated with weight loss, which should be avoided, particularly in older adults, who are also faced with declining anabolic responses to dietary protein intake. Given the increased interest and popularity of plant-based diets, in this study we will compare two distinct calorie-restricted, weight loss diets, both supplemented with weekly exercise, predominantly consisting of either plant-based proteins or animal-based proteins on changes in total body weight, body fat and lean muscle mass, as well as associated changes in metabolic health.
Read the detailed description
Overweight and obesity is a worldwide health problem which are linked to a plethora of age associated chronic diseases such as diabetes, cardiovascular diseases, hypertension and certain cancers. Lifestyle modifications including calorie-restricted diet and/or exercise are effective, non-invasive strategies to combat this burden. However, due to the age-associated muscle atrophy, consisting of reduced muscle functional status and anabolic resistance, calorie restriction to combat obesity is complicated by concomitant loss of skeletal muscle strength and function. Furthermore, in recent times, due to reasons of sustainability and health, there have been substantial attention on the use of alternative proteins to meet dietary protein requirements.
While increased intake of animal proteins is effective in preserving lean muscle mass, to what extent they apply for plant proteins are still a matter of intense debate. Therefore, in this study we will evaluate and compare two distinct calorie restricted dietary interventions, one predominantly consisting of plant-based proteins and another predominantly consisting of animal-based proteins, both supplemented with increased exercise, on their effectiveness to reduce body fat and preserving lean muscle mass. This will be a 16 week, parallel design, randomized dietary intervention trial, in older Chinese adults, with each volunteer being provided with 2 of their 3 main meals per day, along with a mid-morning beverage, made predominantly of either plant protein or animal protein sources and being asked to undertake 3 hours of additional exercise per week. More details provided in sections below.
- Conditions
- Overweight and Obesity
- Being tested
- Low Calorie Animal Protein Meals, Low Calorie Plant Protein Meals
- Keywords
- Body Weight, Body Fat, Muscle Mass
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calorie Animal Protein MealsCombination product
Consume reduced calorie ready meals with animal proteins to substitute participants' two main meals/day plus a serving of malted beverage to be consumed every day for a period of 16 weeks. Additional supervised exercise regime made up of 2 hours of resistance training plus 1 hour of aerobic training per week for a period of 16 weeks.
Low Calorie Plant Protein MealsCombination product
Consume reduced calorie ready meals with plant proteins to substitute participants' two main meals/day plus a serving of soy-based plant protein beverage to be consumed every day for a period of 16 weeks. Additional supervised exercise regime made up of 2 hours of resistance training plus 1 hour of aerobic training per week for a period of 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low-Calorie Control Group | Active comparator | The control group will receive 2x calorie-restricted balanced meals per day, each consisting of a portion of animal proteins (~20g), a portion of vegetables, and a portion of starch (rice/ noodles) per meal. The group will also receive a mid-morning beverage in the form of a malted drink (~150 kcal and ~5g protein). The third meal of the day and any additional snacks will be left to the free choice of the participants, with calorie advice provided by study dietitian. Calorie restriction aims to reduce body weight of individual participants by ~5 - 10%.
The group will also be asked to undergo a supervised mixed exercise regime three days per week, 1 hour per day. The mixed exercise regime will consist of 2 sessions of resistance training and 1 session of aerobic training. Receives: Combination Product: Low Calorie Animal Protein Meals |
| Low-Calorie Treatment Group | Active comparator | The treatment group will receive 2x calorie-restricted balanced meals per day, each consisting of a portion of plant proteins (~25g), a portion of vegetables, and a portion of starch (rice/noodles) per meal. The group will also receive a mid-morning beverage, in the form of a soy-based, plant protein beverage (~120 kcal and 13g protein). The third meal of the day and any additional snacks will be left to the free choice of the participants, with calorie advice provided by study dietitian. Calorie restriction aims to reduce body weight of participants by ~5 - 10%.
The group will also be asked to undergo a supervised mixed exercise regime three days per week, 1 hour per day. The mixed exercise regime will consist of 2 sessions of resistance training and 1 session of aerobic training. Receives: Combination Product: Low Calorie Plant Protein Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass
kg
Measured: 16 weeks (from first to final measurement visits)
Body Fat %
Measured: 16 weeks (from first to final measurement visits)
Muscle Mass
kg
Measured: 16 weeks (from first to final measurement visits)
Secondary outcomes (12)
HbA1c
mmol/mol (%)
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
Fasting glucose
mmol/L
Measured: 16 weeks (from first to final measurement visits), measured every 4 weeks
Fasting insulin
pmol/L
Measured: 16 weeks (from first to final measurement visits), measured every 4 weeks
Oral glucose tolerance test
mmol/L
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride)
mmol/L
Measured: 16 weeks (from first to final measurement visits), measured every 4 weeks
C-Reactive Protein
mg/L
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
IL-6 (Interleukin 6)
pg/mL
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
TNF-α (Tumor Necrosis Factor - alpha)
pg/mL
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
Leptin
ng/mL
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
β-hydroxybutyrate
mmol/L
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
Acetoacetate
mcg/mL
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
TMAO (Trimethylamine N-Oxide)
μM
Measured: 16 weeks (from first to final measurement visits), measured every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start18 Jul 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607628
- Sponsor's protocol ID
- 2022/00205
- Acronym
- WLMR
- Status last verified
- Nov 2022
- First submitted
- 22 Sep 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Intervention With Lean Muscle Mass Retention (WLMR) Study
- ClinicalTrials.gov ID
- NCT05607628
- Acronym / sponsor ID
- WLMR / 2022/00205
- Conditions
- Overweight and Obesity
- Keywords
- Body Weight, Body Fat, Muscle Mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 7 Nov 2022 (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.
Overweight and obesity (i.e., excess body fat) is a worldwide health problem, which predisposes individuals to various metabolic diseases. Weight loss through lifestyle modifications such as dietary calorie restrictions and/or exercise are effective approaches to reduce excess body fat. However, lean muscle mass loss is often an undesired outcome associated with weight loss, which should be avoided, particularly in older adults, who are also faced with declining anabolic responses to dietary protein intake. Given the increased interest and popularity of plant-based diets, in this study we will compare two distinct calorie-restricted, weight loss diets, both supplemented with weekly exercise, predominantly consisting of either plant-based proteins or animal-based proteins on changes in total body weight, body fat and lean muscle mass, as well as associated changes in metabolic health.
Detailed description
Overweight and obesity is a worldwide health problem which are linked to a plethora of age associated chronic diseases such as diabetes, cardiovascular diseases, hypertension and certain cancers. Lifestyle modifications including calorie-restricted diet and/or exercise are effective, non-invasive strategies to combat this burden. However, due to the age-associated muscle atrophy, consisting of reduced muscle functional status and anabolic resistance, calorie restriction to combat obesity is complicated by concomitant loss of skeletal muscle strength and function. Furthermore, in recent times, due to reasons of sustainability and health, there have been substantial attention on the use of alternative proteins to meet dietary protein requirements.
While increased intake of animal proteins is effective in preserving lean muscle mass, to what extent they apply for plant proteins are still a matter of intense debate. Therefore, in this study we will evaluate and compare two distinct calorie restricted dietary interventions, one predominantly consisting of plant-based proteins and another predominantly consisting of animal-based proteins, both supplemented with increased exercise, on their effectiveness to reduce body fat and preserving lean muscle mass. This will be a 16 week, parallel design, randomized dietary intervention trial, in older Chinese adults, with each volunteer being provided with 2 of their 3 main meals per day, along with a mid-morning beverage, made predominantly of either plant protein or animal protein sources and being asked to undertake 3 hours of additional exercise per week. More details provided in sections below.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Calorie Control Group | Active comparator | Combination Product: Low Calorie Animal Protein MealsThe control group will receive 2x calorie-restricted balanced meals per day, each consisting of a portion of animal proteins (~20g), a portion of vegetables, and a portion of starch (rice/ noodles) per meal. The group will also receive a mid-morning beverage in the form of a malted drink (~150 kcal and ~5g protein). The third meal of the day and any additional snacks will be left to the free choice of the participants, with calorie advice provided by study dietitian. Calorie restriction aims to reduce body weight of individual participants by ~5 - 10%. The group will also be asked to undergo a supervised mixed exercise regime three days per week, 1 hour per day. The mixed exercise regime will consist of 2 sessions of resistance training and 1 session of aerobic training. |
| Low-Calorie Treatment Group | Active comparator | Combination Product: Low Calorie Plant Protein MealsThe treatment group will receive 2x calorie-restricted balanced meals per day, each consisting of a portion of plant proteins (~25g), a portion of vegetables, and a portion of starch (rice/noodles) per meal. The group will also receive a mid-morning beverage, in the form of a soy-based, plant protein beverage (~120 kcal and 13g protein). The third meal of the day and any additional snacks will be left to the free choice of the participants, with calorie advice provided by study dietitian. Calorie restriction aims to reduce body weight of participants by ~5 - 10%. The group will also be asked to undergo a supervised mixed exercise regime three days per week, 1 hour per day. The mixed exercise regime will consist of 2 sessions of resistance training and 1 session of aerobic training. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Chinese ethnicity
- Age between 40 to 69 years
- Able to give informed consent
- Body Mass Index (BMI) between 23.0 to 32.5 kg/m2
Key exclusion criteria (26 listed)
- Smoking
- Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc
- Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
- Not willing to stop consumption of probiotic or prebiotic supplements within 4 weeks prior to start of study if currently taking these, as well as during study participation
- Not willing to adhere to diet modification as in the study protocol
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 |
|---|---|---|
| Low Calorie Animal Protein MealsConsume reduced calorie ready meals with animal proteins to substitute participants' two main meals/day plus a serving of malted beverage to be consumed every day for a period of 16 weeks. Additional supervised exercise regime made up of 2 hours of resistance training plus 1 hour of aerobic training per week for a period of 16 weeks. | Combination product | Low-Calorie Control Group |
| Low Calorie Plant Protein MealsConsume reduced calorie ready meals with plant proteins to substitute participants' two main meals/day plus a serving of soy-based plant protein beverage to be consumed every day for a period of 16 weeks. Additional supervised exercise regime made up of 2 hours of resistance training plus 1 hour of aerobic training per week for a period of 16 weeks. | Combination product | Low-Calorie Treatment Group |
Primary outcome
Body Mass
Time frame: 16 weeks (from first to final measurement visits)
kg
Body Fat %
Time frame: 16 weeks (from first to final measurement visits)
Muscle Mass
Time frame: 16 weeks (from first to final measurement visits)
kg
12 secondary outcomes
HbA1c
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
Fasting glucose
Time frame: 16 weeks (from first to final measurement visits), measured every 4 weeks
Fasting insulin
Time frame: 16 weeks (from first to final measurement visits), measured every 4 weeks
Oral glucose tolerance test
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride)
Time frame: 16 weeks (from first to final measurement visits), measured every 4 weeks
C-Reactive Protein
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
IL-6 (Interleukin 6)
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
TNF-α (Tumor Necrosis Factor - alpha)
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
Leptin
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
β-hydroxybutyrate
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
Acetoacetate
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
TMAO (Trimethylamine N-Oxide)
Time frame: 16 weeks (from first to final measurement visits), measured every 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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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 Low Calorie Animal Protein Meals and Low Calorie Plant Protein Meals in people with Overweight and Obesity, 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 5 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
Results are not available in the source record.
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?
Body Mass (time frame: 16 weeks (from first to final measurement visits)). 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 7 Nov 2022.