Weight Loss Intervention With Lean Muscle Mass Retention

NCT05607628 | Unknown

• 1 other identifier: 2022/00205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Body Weight; Body Fat; Muscle Mass

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• HbA1c

  16 weeks (from first to final measurement visits), measured every 8 weeks

• Fasting glucose

  16 weeks (from first to final measurement visits), measured every 4 weeks

• Fasting insulin

  16 weeks (from first to final measurement visits), measured every 4 weeks

• Oral glucose tolerance test

  16 weeks (from first to final measurement visits), measured every 8 weeks

• Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride)

  16 weeks (from first to final measurement visits), measured every 4 weeks

Study Arms (2)

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.

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.

Combination Product: Low Calorie Plant Protein Meals

Interventions

Low Calorie Animal Protein Meals COMBINATION_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 Control Group

Low Calorie Plant Protein Meals COMBINATION_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.

Low-Calorie Treatment Group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: November 7, 2022
• Study Start: July 18, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)