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Diet and Body Composition

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01530724
Acronym
CENTRAL
Enrollment
224
Registered
2012-02-10
Start date
2012-10-31
Completion date
2014-04-30
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

abdominal obesity

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.

Interventions

OTHERWeight-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

OTHERweight loss (-) exercise (PA)

Weight-loss diet strategy without exercise

Sponsors

Ben-Gurion University of the Negev
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
body fat composition0, 6,18 monthschanges in body fat (MRI)
obesity0, 6, 18 monthschanges in weight
abdominal obesity0, 6, 18 monthschanges in waist circumference

Secondary

MeasureTime frameDescription
Inflammatory state0, 6, 18 monthsChanges hsCRP (mg/L) (blood draw)
Metabolomic0, 6, 18 monthsChanges in sub-lipids (blood draw)
Epigenetics0, 6, 18 monthschanges in genes' methylation (blood draw)
Genetic signaturebaselineSNPs (variants) associated with fat distribution and visceral fat (blood draw)
Liver function (blood biomarkers)0, 6, 18 monthsChanges in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw)
Lipid profile0, 6, 18 monthsChanges in lipid biomarkers: total cholesterol (mg/dL), triglycerides (mg/dL), HDLc (mg/dL), LDLc (mg/dL) (blood draw)
Glycemic control0, 6, 18 monthsChanges in fasting glucose (mg/dL) (blood draw)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026