Diet and Body Composition

Phase 3

Completed

• Conditions: Obesity
• Interventions: Other: Weight-loss diet strategy (+) exercise (PA); Other: weight loss (-) exercise (PA)

• Registration Number: NCT01530724
• Lead Sponsor: Ben-Gurion University of the Negev

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
low carb diet	Weight-loss diet strategy (+) exercise (PA)	Weight-loss diet strategy
low carb diet	weight loss (-) exercise (PA)	Weight-loss diet strategy
low fat diet	Weight-loss diet strategy (+) exercise (PA)	Weight-loss diet strategy
low fat diet	weight loss (-) exercise (PA)	Weight-loss diet strategy

Primary Outcome Measures

Name	Time	Method
obesity	0, 6, 18 months	changes in weight
abdominal obesity	0, 6, 18 months	changes in waist circumference
body fat composition	0, 6,18 months	changes in body fat (MRI)

Secondary Outcome Measures

Name	Time	Method
Lipid profile	0, 6, 18 months	Changes in lipid biomarkers: total cholesterol (mg/dL), triglycerides (mg/dL), HDLc (mg/dL), LDLc (mg/dL) (blood draw)
Metabolomic	0, 6, 18 months	Changes in sub-proteins ( blood draw)
Inflammatory state	0, 6, 18 months	Changes hsCRP (mg/L) (blood draw)
Glycemic control	0, 6, 18 months	Changes in insulin (μIU/mL) (blood draw)
Liver function (blood biomarkers)	0, 6, 18 months	Changes in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw)
Genetic signature	baseline	SNPs (variants) associated with fat distribution and visceral fat (blood draw)
Epigenetics	0, 6, 18 months	changes in mRNAs (blood draw)

Trial Locations

Locations (1)

nuclear research center Negev; 🇮🇱 Dimona, Israel