Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081898
• Other study ID #: wt loss_20140305
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2014
• Last updated: March 6, 2014
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 59 Years

Eligibility

Inclusion Criteria:

• 25 <= BMI < 33 kg/m2

Exclusion Criteria:

• type 2 diabetes

• cardiovascular disease

• psychiatric problems

• any medication use

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

Dietary Supplement:
• LCD
approximate 100 kcal/d caloric deficit

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plasma metabolites	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	Yes
Primary	anthropometry	weight, height, BMI, waist circumference, blood pressure	3-year follow-up	Yes
Secondary	biochemistry analysis	total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acids, glucose, insulin, HOMA-IR, Lp-PLA2	3-year follow-up	Yes