Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight Individuals

NCT06802341 | Active Not Recruiting

• 1 other identifier: 2021-192
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Glucose Metabolism Disorders; Obesity, Visceral; Obesity; Endocrine; Insulin Sensitivity; Insulin Resistance

Keywords

Glycaemic control

Outcome Measures

Primary Outcomes (3)

• Gycaemic control

  The primary outcome in this study is the effect on glycaemic control (fasting glucose, insulin, insulin sensitivity).

  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

  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.

  Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t=60 minutes.

Secondary Outcomes (4)

• Postprandial profiles of lipid and inflammation

  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

  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

  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

  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.

Study Arms (3)

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)

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)

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)

Other: Plant based diet

Interventions

Normal protein diet OTHER

Animal-based protein meal plan consisted of 60% carbohydrates, 10% proteins and 30% lipids

Normal protein diet

Animal protein diet OTHER

Animal based high protein meal consisting of 40% carbohydrates, 30% proteins and 30% lipids

Animal based high protein meal

Plant based diet OTHER

Plant based high protein meal consisting of 40% carbohydrates, 30% proteins and 30% lipids

Plant based high protein meal

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Males and females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders; Obesity, Abdominal; Obesity; Insulin Resistance

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Melvin Leow Khee-Shing

Model Details: Randomized, controlled

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 31, 2025
• Study Start: February 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

SG (1)