NCT02081898

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 5, 2014

Last Update Submit

March 6, 2014

Conditions

OverweightObese

Keywords

low calorie dietBMIsphingomyelinL-leucineL-phenylalanine

Outcome Measures

Primary Outcomes (1)

  • anthropometry

    weight, height, BMI, waist circumference, blood pressure

    3-year follow-up

Secondary Outcomes (1)

  • biochemistry analysis

    3-year follow-up

Other Outcomes (1)

  • plasma metabolites

    3-year follow-up

Study Arms (2)

control group

NO INTERVENTION

weight maintenance diet

low calorie diet (LCD) group

EXPERIMENTAL

approximate 100 kcal/d calorie deficit

Dietary Supplement: LCD

Interventions

LCDDIETARY_SUPPLEMENT

approximate 100 kcal/d caloric deficit

Also known as: weight loss diet
low calorie diet (LCD) group

Eligibility Criteria

Age40 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \<= BMI \< 33 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, 120-749, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28053823DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Minjoo Kim, MS

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

June 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

KR(1)