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Weight Loss Intervention With Lean Muscle Mass Retention (WLMR)

Primary Purpose

Overweight and Obesity

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Low Calorie Animal Protein Meals
Low Calorie Plant Protein Meals
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Body Weight, Body Fat, Muscle Mass

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-Calorie Control Group

Low-Calorie Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body Mass
kg
Body Fat %
Muscle Mass
kg

Secondary Outcome Measures

HbA1c
mmol/mol (%)
Fasting glucose
mmol/L
Fasting insulin
pmol/L
Oral glucose tolerance test
mmol/L
Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride)
mmol/L
C-Reactive Protein
mg/L
IL-6 (Interleukin 6)
pg/mL
TNF-α (Tumor Necrosis Factor - alpha)
pg/mL
Leptin
ng/mL
β-hydroxybutyrate
mmol/L
Acetoacetate
mcg/mL
TMAO (Trimethylamine N-Oxide)
μM

Full Information

First Posted
September 22, 2022
Last Updated
November 4, 2022
Sponsor
Clinical Nutrition Research Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05607628
Brief Title
Weight Loss Intervention With Lean Muscle Mass Retention
Acronym
WLMR
Official Title
Weight Loss Intervention With Lean Muscle Mass Retention (WLMR) Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Body Weight, Body Fat, Muscle Mass

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Calorie Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low-Calorie Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Low Calorie Animal Protein Meals
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Low Calorie Plant Protein Meals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass
Description
kg
Time Frame
16 weeks (from first to final measurement visits)
Title
Body Fat %
Time Frame
16 weeks (from first to final measurement visits)
Title
Muscle Mass
Description
kg
Time Frame
16 weeks (from first to final measurement visits)
Secondary Outcome Measure Information:
Title
HbA1c
Description
mmol/mol (%)
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
Fasting glucose
Description
mmol/L
Time Frame
16 weeks (from first to final measurement visits), measured every 4 weeks
Title
Fasting insulin
Description
pmol/L
Time Frame
16 weeks (from first to final measurement visits), measured every 4 weeks
Title
Oral glucose tolerance test
Description
mmol/L
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride)
Description
mmol/L
Time Frame
16 weeks (from first to final measurement visits), measured every 4 weeks
Title
C-Reactive Protein
Description
mg/L
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
IL-6 (Interleukin 6)
Description
pg/mL
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
TNF-α (Tumor Necrosis Factor - alpha)
Description
pg/mL
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
Leptin
Description
ng/mL
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
β-hydroxybutyrate
Description
mmol/L
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
Acetoacetate
Description
mcg/mL
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks
Title
TMAO (Trimethylamine N-Oxide)
Description
μM
Time Frame
16 weeks (from first to final measurement visits), measured every 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Weight Loss Intervention With Lean Muscle Mass Retention

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