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The Effect of Mild Weight Loss on Circulating Metabolite Profiles

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Yonsei University

Status

Completed

Conditions

Weight Loss
Visceral Fat

Treatments

Behavioral: Control group
Behavioral: LCD group

Study type

Interventional

Funder types

Other

Identifiers

NCT03135132
Wt loss_metabolites

Details and patient eligibility

About

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

Full 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).

Enrollment

100 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
Usual dietary intake group
Treatment:
Behavioral: Control group
LCD group
Experimental group
Description:
Low calorie diet (LCD) group (300kcal/day intake reduction)
Treatment:
Behavioral: LCD group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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