Weight Loss Intervention With Lean Muscle Mass Retention (WLMR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Combination product: Low Calorie Animal Protein Meals; Combination product: Low Calorie Plant Protein Meals

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-Calorie Control Group; 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.	Combination product: Low Calorie Animal Protein Meals; 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.
Active Comparator: Low-Calorie Treatment Group; 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.	Combination product: Low Calorie Plant Protein Meals; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass	kg	16 weeks (from first to final measurement visits)
Body Fat %		16 weeks (from first to final measurement visits)
Muscle Mass	kg	16 weeks (from first to final measurement visits)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	mmol/mol (%)	16 weeks (from first to final measurement visits), measured every 8 weeks
Fasting glucose	mmol/L	16 weeks (from first to final measurement visits), measured every 4 weeks
Fasting insulin	pmol/L	16 weeks (from first to final measurement visits), measured every 4 weeks
Oral glucose tolerance test	mmol/L	16 weeks (from first to final measurement visits), measured every 8 weeks
Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride)	mmol/L	16 weeks (from first to final measurement visits), measured every 4 weeks
C-Reactive Protein	mg/L	16 weeks (from first to final measurement visits), measured every 8 weeks
IL-6 (Interleukin 6)	pg/mL	16 weeks (from first to final measurement visits), measured every 8 weeks
TNF-α (Tumor Necrosis Factor - alpha)	pg/mL	16 weeks (from first to final measurement visits), measured every 8 weeks
Leptin	ng/mL	16 weeks (from first to final measurement visits), measured every 8 weeks
β-hydroxybutyrate	mmol/L	16 weeks (from first to final measurement visits), measured every 8 weeks
Acetoacetate	mcg/mL	16 weeks (from first to final measurement visits), measured every 8 weeks
TMAO (Trimethylamine N-Oxide)	μM	16 weeks (from first to final measurement visits), measured every 8 weeks

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Body Weight; Muscle Mass; Body Fat
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 2022/00205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No