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Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LCD
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring low calorie diet, BMI, sphingomyelin, L-leucine, L-phenylalanine

Eligibility Criteria

40 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 25 <= BMI < 33 kg/m2

Exclusion Criteria:

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

Sites / Locations

  • Laboratory of Clinical Nutrigenetics/Nutrigenomics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

low calorie diet (LCD) group

Arm Description

weight maintenance diet

approximate 100 kcal/d calorie deficit

Outcomes

Primary Outcome Measures

anthropometry
weight, height, BMI, waist circumference, blood pressure

Secondary Outcome Measures

biochemistry analysis
total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acids, glucose, insulin, HOMA-IR, Lp-PLA2

Full Information

First Posted
March 5, 2014
Last Updated
March 6, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02081898
Brief Title
Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids
Official Title
Three-year Mild Calorie Restriction Partially Protects Against Age-related Increase in Sphingomyelin and Reduces Obesity-associated Amino Acids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
low calorie diet, BMI, sphingomyelin, L-leucine, L-phenylalanine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
weight maintenance diet
Arm Title
low calorie diet (LCD) group
Arm Type
Experimental
Arm Description
approximate 100 kcal/d calorie deficit
Intervention Type
Dietary Supplement
Intervention Name(s)
LCD
Other Intervention Name(s)
weight loss diet
Intervention Description
approximate 100 kcal/d caloric deficit
Primary Outcome Measure Information:
Title
anthropometry
Description
weight, height, BMI, waist circumference, blood pressure
Time Frame
3-year follow-up
Secondary Outcome Measure Information:
Title
biochemistry analysis
Description
total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acids, glucose, insulin, HOMA-IR, Lp-PLA2
Time Frame
3-year follow-up
Other Pre-specified Outcome Measures:
Title
plasma metabolites
Description
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)
Time Frame
3-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25 <= BMI < 33 kg/m2 Exclusion Criteria: type 2 diabetes cardiovascular disease psychiatric problems any medication use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minjoo Kim, MS
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Clinical Nutrigenetics/Nutrigenomics
City
Seoul
ZIP/Postal Code
120-749
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28053823
Citation
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.
Results Reference
derived

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Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

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