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Completed

NCT Number: NCT03135132

The Effect of Mild Weight Loss on Circulating Metabolite Profiles

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

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Key information

Conditions

Visceral Fat Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University

Seoul, 03722, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Behavioral

Recommend to consume usual diet during 12-week study period

LCD group

Behavioral

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

Primary outcomes

  1. Visceral fat area at L4 (CT)

    Time frame: At baseline

  2. Visceral fat area at L4 (CT)

    Time frame: At 12-week follow-up

  3. Change in visceral fat area at L4 from baseline

    Time frame: At baseline and 12-week follow-up

  4. Putatively identified plasma metabolites (Normalized peak intensities)

    Time frame: At baseline

  5. Putatively identified plasma metabolites (Normalized peak intensities)

    Time frame: At 12-week follow-up

  6. Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline

    Time frame: At baseline and 12-week follow-up

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 1, 2017
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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