Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06802341

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 40 Years
SexFemale
Healthy volunteersAccepted
ConditionHealthy, Glucose Metabolism Disorders, Obesity, Visceral, Obesity; Endocrine, Insulin Sensitivity, Insulin Resistance

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * • 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) * Has claustrophobia, trypanophobia, or hemophobia * Unwilling to consume study foods * Inadequate fluency in the English language * Unable to understand the study procedures and signs forms providing written informed consent to participate in the study. * Is a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted

Treatments and study arms

Normal protein diet

Other

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

Animal protein diet

Other

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

Plant based diet

Other

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

Primary outcomes

Gycaemic controlBlood 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

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

Energy expenditure and fuel utilizationAssessed 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

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

Postprandial amino acids and proteomics profilesBlood will be sampled at timepoints, t = 0 minute (Baseline) and at t=60 minutes.

To identify novel biomarkers and gain insights to investigate phenotypic differences of MONW individuals.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Clinical Nutrition Research Centre🇸🇬 Singapore, Singapore, Singapore