The Effect of Mild Weight Loss on Circulating Metabolite Profiles

Not Applicable

Completed

• Conditions: Weight Loss; Visceral Fat
• Interventions: Behavioral: Control group; Behavioral: LCD group

• Registration Number: NCT03135132
• Lead Sponsor: Yonsei University

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 Timeline

• Study Start: 2015-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Usual dietary intake group
LCD group	LCD group	Low calorie diet (LCD) group (300kcal/day intake reduction)

Primary Outcome Measures

Name	Time	Method
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 12-week follow-up
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline	At baseline and 12-week follow-up

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of