Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

Phase 3

Completed

• Conditions: Overweight; Obese

• Registration Number: NCT02081898
• Lead Sponsor: Yonsei University

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.

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 Timeline

• Study Start: 2010-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Study First Posted: 2014-03-07
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 25 <= BMI < 33 kg/m2

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
anthropometry	3-year follow-up	weight, height, BMI, waist circumference, blood pressure

Secondary Outcome Measures

Name	Time	Method
biochemistry analysis	3-year follow-up	total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acids, glucose, insulin, HOMA-IR, Lp-PLA2

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics; 🇰🇷 Seoul, Korea, Republic of