Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

March 6, 2014 updated by: Yonsei University

Three-year Mild Calorie Restriction Partially Protects Against Age-related Increase in Sphingomyelin and Reduces Obesity-associated Amino Acids

The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in the extended plasma metabolites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overweight/obese subjects (25≤ BMI <33 kg/m2) aged 40 to 59 years consumed a LCD (an approximate 100 kcal/day calorie deficit) or a weight-maintenance diet (control) in a randomized, controlled design with 3-year intervention period.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-749
        • Laboratory of Clinical Nutrigenetics/Nutrigenomics

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

40 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 25 <= BMI < 33 kg/m2

Exclusion Criteria:

  • type 2 diabetes
  • cardiovascular disease
  • psychiatric problems
  • any medication use

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
weight maintenance diet
EXPERIMENTAL: low calorie diet (LCD) group
approximate 100 kcal/d calorie deficit
Dietary supplement: LCD
approximate 100 kcal/d caloric deficit
Other Names:
  • weight loss diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometry
Time Frame: 3-year follow-up
weight, height, BMI, waist circumference, blood pressure
3-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemistry analysis
Time Frame: 3-year follow-up
total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acids, glucose, insulin, HOMA-IR, Lp-PLA2
3-year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma metabolites
Time Frame: 3-year follow-up
palmitic amide, oleamide, lysoPC (16:1, 16:0, 17:0, 18:2, 18:1, 18:0, 20:4, 20:3, 22:6), PC (16:0/20:5, 16:0/20:5, 18:2/18:2, 18:0/20:4), lactosylceramide (d18:1/12:2)
3-year follow-up

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Minjoo Kim, MS, 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

June 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (ESTIMATE)

March 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wt loss_20140305

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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