AzTrials
AzTrials

ObesityPhase 3CENTRALNCT01530724

Diet and Body Composition

A Phase 3 study testing Weight-loss diet strategy (+) exercise (PA) and weight loss (-) exercise (PA) in people with Obesity, run by Ben-Gurion University of the Negev at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Weight-loss diet strategy (+) exercise (PA) and weight loss (-) exercise (PA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteIsrael
Study dates
Oct 2012to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Israel1 site

  • nuclear research center Negev

    Dimona

Other trials in Israel

About this study

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

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.

Conditions
Obesity
Being tested
Weight-loss diet strategy (+) exercise (PA), weight loss (-) exercise (PA)
Keywords
abdominal obesity
Medical subject headings
Obesity, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT01530724
Study groupRoleWhat they receive
low fat dietExperimentalWeight-loss diet strategy
Receives: Other: Weight-loss diet strategy (+) exercise (PA); Other: weight loss (-) exercise (PA)
low carb dietExperimentalWeight-loss diet strategy
Receives: Other: Weight-loss diet strategy (+) exercise (PA); Other: weight loss (-) exercise (PA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body fat composition

    changes in body fat (MRI)

    Measured: 0, 6,18 months

  2. obesity

    changes in weight

    Measured: 0, 6, 18 months

  3. abdominal obesity

    changes in waist circumference

    Measured: 0, 6, 18 months

Secondary outcomes (10)

  1. Lipid profile

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

    Measured: 0, 6, 18 months

  2. Glycemic control

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

    Measured: 0, 6, 18 months

  3. Glycemic control

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

    Measured: 0, 6, 18 months

  4. Inflammatory state

    Changes hsCRP (mg/L) (blood draw)

    Measured: 0, 6, 18 months

  5. Metabolomic

    Changes in sub-lipids (blood draw)

    Measured: 0, 6, 18 months

  6. Metabolomic

    Changes in sub-proteins ( blood draw)

    Measured: 0, 6, 18 months

  7. Liver function (blood biomarkers)

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

    Measured: 0, 6, 18 months

  8. Genetic signature

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

    Measured: baseline

  9. Epigenetics

    changes in genes' methylation (blood draw)

    Measured: 0, 6, 18 months

  10. Epigenetics

    changes in mRNAs (blood draw)

    Measured: 0, 6, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01530724
Sponsor's protocol ID
ISF256/09
Other IDs
256/09
Acronym
CENTRAL
Status last verified
Oct 2020
First submitted
8 Feb 2012
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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, Bluher 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.

    PubMed 18635428

  • Klein H, Alufer L, Goldberg Toren DT, Pachter D, Kamer O, Ebstein Karamani N, Chassidim Y, Shelef I, Rudich A, Yoel U, Ben-Arie G, Zelicha H, Yaskolka Meir A, Tsaban G, Bartal C, Bluher M, Stumvoll M, Ceglarek U, Isermann B, Qi L, Stampfer MJ, Hu FB, Shai I. Lifestyle-Induced Visceral Fat Loss as a Key Target for Durable Cardiometabolic Health: MRI-Assessed 5- and 10-Year Follow-Up After 2 Clinical Trials. Circulation. 2026 Jul 7;154(1):16-27. doi: 10.1161/CIRCULATIONAHA.125.079009. Epub 2026 Jun 2.

    PubMed 42227111

  • Klein H, Pachter D, Goldberg Toren DT, Kamer O, Alufer L, Ebstein Karamani N, Chassidim Y, Shelef I, Rudich A, Yoel U, Ben-Arie G, Zelicha H, Yaskolka Meir A, Tsaban G, Bartal C, Bluher M, Stumvoll M, Ceglarek U, Isermann B, Qi L, Stampfer MJ, Hu FB, Shai I. How effective is rejoining a long-term weight loss program? The 5- and 10-year MRI-assessed Follow Interventions Trial (FIT) project. BMC Med. 2026 Jan 30;24(1):121. doi: 10.1186/s12916-026-04663-9.

    PubMed 41612310

  • Yaskolka Meir A, Tsaban G, Rinott E, Zelicha H, Schwarzfuchs D, Gepner Y, Rudich A, Shelef I, Bluher M, Stumvoll M, Ceglarek U, Isermann B, Kloting N, Keller M, Kovacs P, Qi L, Wang DD, Liang L, Hu FB, Stampfer MJ, Shai I. Individual response to lifestyle interventions: a pooled analysis of three long-term weight loss trials. Eur J Prev Cardiol. 2025 Nov 11;32(16):1660-1670. doi: 10.1093/eurjpc/zwaf308.

    PubMed 40472282

  • Klein H, Zelicha H, Yaskolka Meir A, Rinott E, Tsaban G, Kaplan A, Chassidim Y, Gepner Y, Bluher M, Ceglarek U, Isermann B, Stumvoll M, Shelef I, Qi L, Li J, Hu FB, Stampfer MJ, Shai I. Visceral adipose tissue area and proportion provide distinct reflections of cardiometabolic outcomes in weight loss; pooled analysis of MRI-assessed CENTRAL and DIRECT PLUS dietary randomized controlled trials. BMC Med. 2025 Feb 4;23(1):57. doi: 10.1186/s12916-025-03891-9.

    PubMed 39901232

  • Heianza Y, Krohn K, Yaskolka Meir A, Wang X, Ziesche S, Ceglarek U, Bluher M, Keller M, Kovacs P, Shai I, Qi L. Changes in Circulating miR-375-3p and Improvements in Visceral and Hepatic Fat Contents in Response to Lifestyle Interventions: The CENTRAL Trial. Diabetes Care. 2022 Aug 1;45(8):1911-1913. doi: 10.2337/dc21-2517.

    PubMed 35657082

  • Heianza Y, Krohn K, Xue Q, Yaskolka Meir A, Ziesche S, Ceglarek U, Bluher M, Keller M, Kovacs P, Shai I, Qi L. Changes in circulating microRNAs-99/100 and reductions of visceral and ectopic fat depots in response to lifestyle interventions: the CENTRAL trial. Am J Clin Nutr. 2022 Jul 6;116(1):165-172. doi: 10.1093/ajcn/nqac070.

    PubMed 35348584

  • Tsaban G, Bilitzky-Kopit A, Yaskolka Meir A, Zelicha H, Gepner Y, Shelef I, Orr O, Chassidim Y, Sarusi B, Ceglarek U, Stumvoll M, Bluher M, Stampfer MJ, Shai I, Schwarzfuchs D. The Effect of Weight-Loss Interventions on Cervical and Chin Subcutaneous Fat Depots; the CENTRAL Randomized Controlled Trial. Nutrients. 2021 Oct 27;13(11):3827. doi: 10.3390/nu13113827.

    PubMed 34836081

  • Yaskolka Meir A, Keller M, Muller L, Bernhart SH, Tsaban G, Zelicha H, Rinott E, Kaplan A, Gepner Y, Shelef I, Schwarzfuchs D, Ceglarek U, Stadler P, Bluher M, Stumvoll M, Kovacs P, Shai I. Effects of lifestyle interventions on epigenetic signatures of liver fat: Central randomized controlled trial. Liver Int. 2021 Sep;41(9):2101-2111. doi: 10.1111/liv.14916. Epub 2021 May 28.

    PubMed 33938135

  • Yaskolka Meir A, Keller M, Bernhart SH, Rinott E, Tsaban G, Zelicha H, Kaplan A, Schwarzfuchs D, Shelef I, Gepner Y, Li J, Lin Y, Bluher M, Ceglarek U, Stumvoll M, Stadler PF, Stampfer MJ, Kovacs P, Liang L, Shai I. Lifestyle weight-loss intervention may attenuate methylation aging: the CENTRAL MRI randomized controlled trial. Clin Epigenetics. 2021 Mar 4;13(1):48. doi: 10.1186/s13148-021-01038-0.

    PubMed 33663610

  • Gepner Y, Goldstein N, Shelef I, Schwarzfuchs D, Zelicha H, Meir AY, Tsaban G, Grossman E. Dissociation Between Long-term Weight Loss Intervention and Blood Pressure: an 18-month Randomized Controlled Trial. J Gen Intern Med. 2021 Aug;36(8):2300-2306. doi: 10.1007/s11606-021-06655-2. Epub 2021 Feb 25.

    PubMed 33634382

  • Gepner Y, Shelef I, Komy O, Cohen N, Schwarzfuchs D, Bril N, Rein M, Serfaty D, Kenigsbuch S, Zelicha H, Yaskolka Meir A, Tene L, Bilitzky A, Tsaban G, Chassidim Y, Sarusy B, Ceglarek U, Thiery J, Stumvoll M, Bluher M, Stampfer MJ, Rudich A, Shai I. The beneficial effects of Mediterranean diet over low-fat diet may be mediated by decreasing hepatic fat content. J Hepatol. 2019 Aug;71(2):379-388. doi: 10.1016/j.jhep.2019.04.013. Epub 2019 May 8.

    PubMed 31075323

  • Tene L, Shelef I, Schwarzfuchs D, Gepner Y, Yaskolka Meir A, Tsaban G, Zelicha H, Bilitzky A, Komy O, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Chassidim Y, Sarusy B, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Stampfer MJ, Rudich A, Shai I. The effect of long-term weight-loss intervention strategies on the dynamics of pancreatic-fat and morphology: An MRI RCT study. Clin Nutr ESPEN. 2018 Apr;24:82-89. doi: 10.1016/j.clnesp.2018.01.008. Epub 2018 Feb 6.

    PubMed 29576369

  • Gepner Y, Shelef I, Schwarzfuchs D, Cohen N, Bril N, Rein M, Tsaban G, Zelicha H, Yaskolka Meir A, Tene L, Sarusy B, Rosen P, Hoffman JR, Stout JR, Thiery J, Ceglarek U, Stumvoll M, Bluher M, Stampfer MJ, Shai I. Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial. PLoS One. 2017 Nov 30;12(11):e0188431. doi: 10.1371/journal.pone.0188431. eCollection 2017.

    PubMed 29190720

  • Gepner Y, Shelef I, Schwarzfuchs D, Zelicha H, Tene L, Yaskolka Meir A, Tsaban G, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Komy O, Wolak A, Chassidim Y, Golan R, Avni-Hassid H, Bilitzky A, Sarusi B, Goshen E, Shemesh E, Henkin Y, Stumvoll M, Bluher M, Thiery J, Ceglarek U, Rudich A, Stampfer MJ, Shai I. Effect of Distinct Lifestyle Interventions on Mobilization of Fat Storage Pools: CENTRAL Magnetic Resonance Imaging Randomized Controlled Trial. Circulation. 2018 Mar 13;137(11):1143-1157. doi: 10.1161/CIRCULATIONAHA.117.030501. Epub 2017 Nov 15.

    PubMed 29142011

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Weight-loss diet strategy (+) exercise (PA) and weight loss (-) exercise (PA) in people with Obesity, run by Ben-Gurion University of the Negev at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body fat composition (time frame: 0, 6,18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01530724, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in