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Completed

NCT Number: NCT02081898

Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, 120-749, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 25 <= BMI < 33 kg/m2

Exclusion criteria

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

Treatment and study plan

LCD

Dietary Supplement

approximate 100 kcal/d caloric deficit

Other names: weight loss diet

Primary outcomes

  1. anthropometry

    Time frame: 3-year follow-up

    weight, height, BMI, waist circumference, blood pressure

Secondary outcomes

  1. biochemistry analysis

    Time frame: 3-year follow-up

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

Other outcomes

  1. plasma metabolites

    Time frame: 3-year follow-up

    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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 7, 2014
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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