The Effect of Mild Weight Loss on Circulating Metabolite Profiles

Study Overview
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Brief Summary
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To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

Detailed Description
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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).

Official Title
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Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss

Conditions
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Visceral Fat, Weight Loss

Intervention / Treatment
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* Behavioral: Control group
* Behavioral: LCD group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Usual dietary intake group | Behavioral: Control group<br>* Recommend to consume usual diet during 12-week study period<br>|
| Experimental: LCD group<br>Low calorie diet (LCD) group (300kcal/day intake reduction) | Behavioral: LCD group<br>* Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral fat area at L4 (CT) |  | At baseline | 
| Visceral fat area at L4 (CT) |  | At 12-week follow-up | 
| Change in visceral fat area at L4 from baseline |  | At baseline and 12-week follow-up | 
| Putatively identified plasma metabolites (Normalized peak intensities) |  | At baseline | 
| Putatively identified plasma metabolites (Normalized peak intensities) |  | At 12-week follow-up | 
| Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline |  | At baseline and 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High visceral fat, Low calorie diet, Mild weight loss, Metabolomics, Metabolites, Acylcarnitines