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OpenTrials
Completed

NCT Number: NCT01530724

Diet and Body Composition

The investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

nuclear research center Negev

Dimona, Israel

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elevated waist circumference:
  • Men: > 40 inches (102 cm)
  • Women> 35 inches (88 cm)
  • Poor dieters with TG>150mg/dL and high-density-lipoprotein cholesterol [HDL-c] <40 mg/dL for men and <50 mg/dL for women

Exclusion criteria

  • Pregnant or lactating women
  • Serum creatinine LT 2 mg/dl
  • Disturbed liver function (LT 3 fold level of ALT and AST enzymes)
  • Active cancer
  • Individuals who cannot start physical activity in the gym
  • Individuals that are highly physically active (more than 4 hours/week)
  • Active in other nutritional trial

Treatment and study plan

Weight-loss diet strategy (+) exercise (PA)

Other

Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training

weight loss (-) exercise (PA)

Other

Weight-loss diet strategy without exercise

Primary outcomes

  1. body fat composition

    Time frame: 0, 6,18 months

    changes in body fat (MRI)

  2. obesity

    Time frame: 0, 6, 18 months

    changes in weight

  3. abdominal obesity

    Time frame: 0, 6, 18 months

    changes in waist circumference

Secondary outcomes

  1. Lipid profile

    Time frame: 0, 6, 18 months

    Changes in lipid biomarkers: total cholesterol (mg/dL), triglycerides (mg/dL), HDLc (mg/dL), LDLc (mg/dL) (blood draw)

  2. Glycemic control

    Time frame: 0, 6, 18 months

    Changes in fasting glucose (mg/dL) (blood draw)

  3. Glycemic control

    Time frame: 0, 6, 18 months

    Changes in insulin (μIU/mL) (blood draw)

  4. Inflammatory state

    Time frame: 0, 6, 18 months

    Changes hsCRP (mg/L) (blood draw)

  5. Metabolomic

    Time frame: 0, 6, 18 months

    Changes in sub-lipids (blood draw)

  6. Metabolomic

    Time frame: 0, 6, 18 months

    Changes in sub-proteins ( blood draw)

  7. Liver function (blood biomarkers)

    Time frame: 0, 6, 18 months

    Changes in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw)

  8. Genetic signature

    Time frame: baseline

    SNPs (variants) associated with fat distribution and visceral fat (blood draw)

  9. Epigenetics

    Time frame: 0, 6, 18 months

    changes in genes' methylation (blood draw)

  10. Epigenetics

    Time frame: 0, 6, 18 months

    changes in mRNAs (blood draw)

Sponsors and collaborators

Lead sponsor

Ben-Gurion University of the Negev

Other

Registry information

Official study title

Effect of Weight-loss Diet Strategies and Exercise on Dynamics of Body Fat Depots and Metabolic Rate

Acronym: CENTRAL

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2012
Registry last updated
Oct 23, 2020

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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