Diet and Body Composition

Obesity Clinical Trial

— CENTRAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530724
• Other study ID #: ISF256/09
• Secondary ID: 256/09
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: October 2020
• Source: Ben-Gurion University of the Negev
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Weight-loss diet strategy (+) exercise (PA)
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)
Weight-loss diet strategy without exercise

Locations

Country	Name	City	State
Israel	nuclear research center Negev	Dimona

Sponsors (1)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681. Erratum in: N Engl J Med. 2009 Dec 31;361(27):2681. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body fat composition	changes in body fat (MRI)	0, 6,18 months
Primary	obesity	changes in weight	0, 6, 18 months
Primary	abdominal obesity	changes in waist circumference	0, 6, 18 months
Secondary	Lipid profile	Changes in lipid biomarkers: total cholesterol (mg/dL), triglycerides (mg/dL), HDLc (mg/dL), LDLc (mg/dL) (blood draw)	0, 6, 18 months
Secondary	Glycemic control	Changes in fasting glucose (mg/dL) (blood draw)	0, 6, 18 months
Secondary	Glycemic control	Changes in insulin (µIU/mL) (blood draw)	0, 6, 18 months
Secondary	Inflammatory state	Changes hsCRP (mg/L) (blood draw)	0, 6, 18 months
Secondary	Metabolomic	Changes in sub-lipids (blood draw)	0, 6, 18 months
Secondary	Metabolomic	Changes in sub-proteins ( blood draw)	0, 6, 18 months
Secondary	Liver function (blood biomarkers)	Changes in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw)	0, 6, 18 months
Secondary	Genetic signature	SNPs (variants) associated with fat distribution and visceral fat (blood draw)	baseline
Secondary	Epigenetics	changes in genes' methylation (blood draw)	0, 6, 18 months
Secondary	Epigenetics	changes in mRNAs (blood draw)	0, 6, 18 months