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| ID | Type | Description | Link |
|---|---|---|---|
| 256/09 | Other Grant/Funding Number | ISF256/09 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low fat diet | Experimental | Weight-loss diet strategy |
|
| low carb diet | Experimental | Weight-loss diet strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| body fat composition | changes in body fat (MRI) | 0, 6,18 months |
| obesity | changes in weight | 0, 6, 18 months |
| abdominal obesity | changes in waist circumference | 0, 6, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Glycemic control | Changes in fasting glucose (mg/dL) (blood draw) |
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Inclusion Criteria:
Elevated waist circumference:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| nuclear research center Negev | Dimona | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18635428 | Background | 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. | |
| 42227111 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| weight loss (-) exercise (PA) | Other | Weight-loss diet strategy without exercise |
|
| 0, 6, 18 months |
| Glycemic control | Changes in insulin (μIU/mL) (blood draw) | 0, 6, 18 months |
| Inflammatory state | Changes hsCRP (mg/L) (blood draw) | 0, 6, 18 months |
| Metabolomic | Changes in sub-lipids (blood draw) | 0, 6, 18 months |
| Metabolomic | Changes in sub-proteins ( blood draw) | 0, 6, 18 months |
| Liver function (blood biomarkers) | Changes in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw) | 0, 6, 18 months |
| Genetic signature | SNPs (variants) associated with fat distribution and visceral fat (blood draw) | baseline |
| Epigenetics | changes in genes' methylation (blood draw) | 0, 6, 18 months |
| Epigenetics | changes in mRNAs (blood draw) | 0, 6, 18 months |
| Derived |
| 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 Jun 2. doi: 10.1161/CIRCULATIONAHA.125.079009. Online ahead of print. |
| 41612310 | Derived | 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. |
| 40472282 | Derived | 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. |
| 39901232 | Derived | 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. |
| 35657082 | Derived | 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. |
| 35348584 | Derived | 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. |
| 34836081 | Derived | 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. |
| 33938135 | Derived | 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. |
| 33663610 | Derived | 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. |
| 33634382 | Derived | 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. |
| 31075323 | Derived | 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. |
| 29576369 | Derived | 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. |
| 29190720 | Derived | 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. |
| 29142011 | Derived | 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. |
| 28814394 | Derived | Tsaban G, Wolak A, Avni-Hassid H, Gepner Y, Shelef I, Henkin Y, Schwarzfuchs D, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Tene L, Zelicha H, Yaskolka-Meir A, Komy O, Bilitzky A, Chassidim Y, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Dicker D, Rudich A, Stampfer MJ, Shai I. Dynamics of intrapericardial and extrapericardial fat tissues during long-term, dietary-induced, moderate weight loss. Am J Clin Nutr. 2017 Oct;106(4):984-995. doi: 10.3945/ajcn.117.157115. Epub 2017 Aug 16. |
| 28501343 | Derived | Zelicha H, Schwarzfuchs D, Shelef I, Gepner Y, Tsaban G, Tene L, Yaskolka Meir A, Bilitzky A, Komy O, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Chassidim Y, Sarusi B, Thiery J, Ceglarek U, Stumvoll M, Bluher M, Haviv YS, Stampfer MJ, Rudich A, Shai I. Changes of renal sinus fat and renal parenchymal fat during an 18-month randomized weight loss trial. Clin Nutr. 2018 Aug;37(4):1145-1153. doi: 10.1016/j.clnu.2017.04.007. Epub 2017 May 2. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |