The Effect of Mild Weight Loss on Circulating Metabolite Profiles

April 26, 2017 updated by: Yonsei University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wt loss_metabolites

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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