A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration

Conditions

CHD, Obesity

Brief summary

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Detailed description

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Dafna Pachter, Hadar Klein, Omer Kamer, Dana Tamar Goldberg Toren, Liav Alufer et al. (32 authors)

Nature Communications2026-03-26

10.1038/s41467-026-71141-4

Individual response to lifestyle interventions: a pooled analysis of three long-term weight loss trials.

Yaskolka Meir A, Tsaban G, Rinott E, Zelicha H, Schwarzfuchs D, Gepner Y, Rudich A, Shelef I, Blüher M, Stumvoll M, Ceglarek U, Isermann B, Klöting N, Keller M, Kovacs P, Qi L, Wang DD, Liang L, Hu FB, Stampfer MJ, Shai I.

2025-11-013 citations

10.1093/eurjpc/zwaf308

Weight-loss diets and 2-y changes in circulating amino acids in 2 randomized intervention trials.

Zheng Y, Ceglarek U, Huang T, Li L, Rood J, Ryan DH, Bray GA, Sacks FM, Schwarzfuchs D, Thiery J, Shai I, Qi L.

2016-01-2072 citations

10.3945/ajcn.115.117689

Effects of a 2-y dietary weight-loss intervention on cholesterol metabolism in moderately obese men.

Leichtle AB, Helmschrodt C, Ceglarek U, Shai I, Henkin Y, Schwarzfuchs D, Golan R, Gepner Y, Stampfer MJ, Blüher M, Stumvoll M, Thiery J, Fiedler GM.

2011-09-2111 citations

10.3945/ajcn.111.018119

Dietary intervention induces flow of changes within biomarkers of lipids, inflammation, liver enzymes, and glycemic control.

Golan R, Tirosh A, Schwarzfuchs D, Harman-Boehm I, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Shai I, DIRECT Group.

2011-08-0610 citations

10.1016/j.nut.2011.04.001

Dairy calcium intake, serum vitamin D, and successful weight loss.

Shahar DR, Schwarzfuchs D, Fraser D, Vardi H, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ, Shai I, DIRECT Group.

2010-09-0144 citations

10.3945/ajcn.2010.29355

Dietary intervention to reverse carotid atherosclerosis.

Shai I, Spence JD, Schwarzfuchs D, Henkin Y, Parraga G, Rudich A, Fenster A, Mallett C, Liel-Cohen N, Tirosh A, Bolotin A, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ, DIRECT Group.

2010-03-01151 citations

10.1161/circulationaha.109.879254

Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet.

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.

2008-07-011,079 citations

10.1056/nejmoa0708681

Interventions

BEHAVIORALdietary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* BMI\>27 * age\>40 * History of CHD or diabetes in any age or BMI level

Exclusion criteria

* Pregnant or lactating women. * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Serum creatinine \> 3 mg/dl. * Liver dysfunction ( ³ 2 fold level of ALT and AST enzymes). * Participation in another trial in which active intervention is being received. * Any intestinal problem that would prevent the patient from eating one of the test diets (for example, gastric stapling that might prevent consumption of vegetables).

Design outcomes

Primary

Measure	Time frame
weight loss	—

Secondary

Measure	Time frame
CVD mediators measurements	—

Countries

Israel

Outcome results

None listed