Diet and Body Composition (CENTRAL)

Ben-Gurion University of the Negev

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Other: weight loss (-) exercise (PA); Other: Weight-loss diet strategy (+) exercise (PA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01530724

256/09 (Other Grant/Funding Number)

ISF256/09

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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224 participants in 2 patient groups

low fat diet

Experimental group

Description:

Weight-loss diet strategy

Treatment:

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

Other: weight loss (-) exercise (PA)

low carb diet

Experimental group

Description:

Weight-loss diet strategy

Treatment:

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

Other: weight loss (-) exercise (PA)