The Effect of Mild Weight Loss on Circulating Metabolite Profiles

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03135132

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Visceral Fat Weight Loss	Behavioral: Control group Behavioral: LCD group	N/A

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

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Usual dietary intake group	Behavioral: Control group Recommend to consume usual diet during 12-week study period
Experimental: LCD group Low calorie diet (LCD) group (300kcal/day intake reduction)	Behavioral: LCD group 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

Arm

Intervention/Treatment

Placebo Comparator: Control group

Usual dietary intake group

Behavioral: Control group

Recommend to consume usual diet during 12-week study period

Experimental: LCD group

Low calorie diet (LCD) group (300kcal/day intake reduction)

Behavioral: LCD group

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

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