NCT06802341Active, not recruiting
Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight Individuals
Energy Metabolism and Acute Effects of Protein Diets in Metabolically Obese Normal Weight (MONW) Individuals
Source: ClinicalTrials.gov · Last updated 31 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 17 Jan 2025
- Start date
- 1 Feb 2022
- Primary completion date
- Feb 2025
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Diseases
- Obesity
- NCT number
- NCT06802341
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 1 Feb 2022 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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
Who the study is looking for
- 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
Age in the registry: 21 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Nutrition Research Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.