Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

NCT ID: NCT02081898

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Obese

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

weight maintenance diet

Group Type NO_INTERVENTION

No interventions assigned to this group

low calorie diet (LCD) group

approximate 100 kcal/d calorie deficit

Group Type EXPERIMENTAL

LCD

Intervention Type DIETARY_SUPPLEMENT

approximate 100 kcal/d caloric deficit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LCD

approximate 100 kcal/d caloric deficit

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

weight loss diet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 25 \<= BMI \< 33 kg/m2

Exclusion Criteria

* type 2 diabetes
* cardiovascular disease
* psychiatric problems
* any medication use
Minimum Eligible Age

40 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Minjoo Kim, MS

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Kim M, Lee SH, Lee JH. Global Metabolic Profiling of Plasma Shows that Three-Year Mild-Caloric Restriction Lessens an Age-Related Increase in Sphingomyelin and Reduces L-leucine and L-phenylalanine in Overweight and Obese Subjects. Aging Dis. 2016 Dec 1;7(6):721-733. doi: 10.14336/AD.2016.0330. eCollection 2016 Dec.

Reference Type DERIVED
PMID: 28053823 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

wt loss_20140305

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.