Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visceral fat area at L4 (CT)
Study Overview
Brief Summary
To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.
Detailed Description
Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Able to give informed consent
- •20-65 years old
- •Males and females
- •Overweight (25.0 kg/m²≤ Body mass index <30 kg/m²)
- •Nondiabetic (Fasting glucose <126 mg/dL)
Exclusion Criteria
- •Unstable body weight (body weight change >1 kg within 3 months before screening)
- •Consumption of medication that affects body weight or energy expenditure
- •Pregnancy or breast-feeding
- •Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
- •Liver disease, kidney disease, or gastrointestinal disease
- •Acute or chronic infections
- •Any acute or chronic disease requiring treatment
Arms & Interventions
Control group
Usual dietary intake group
Intervention: Control group (Behavioral)
LCD group
Low calorie diet (LCD) group (300kcal/day intake reduction)
Intervention: LCD group (Behavioral)
Outcomes
Primary Outcomes
Visceral fat area at L4 (CT)
Time Frame: At 12-week follow-up
Change in visceral fat area at L4 from baseline
Time Frame: At baseline and 12-week follow-up
Putatively identified plasma metabolites (Normalized peak intensities)
Time Frame: At 12-week follow-up
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline
Time Frame: At baseline and 12-week follow-up
Visceral fat area at L4 (CT)
Time Frame: At baseline
Putatively identified plasma metabolites (Normalized peak intensities)
Time Frame: At baseline
Secondary Outcomes
No secondary outcomes reported