Evidence map›Paper›PMID 18635428›Full record

Trial reportThe New England journal of medicine2008

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

Iris Shai, Dan Schwarzfuchs, Yaakov Henkin, Danit R Shahar, Shula Witkow, Ilana Greenberg, Rachel Golan, Drora Fraser, Arkady Bolotin, Hilel Vardi and 14 more

Erratum issued 10 registry-linked trialsOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 10 registered trials, which are not on this map. Cited by 752 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
752citing papers in PubMed, 23 pooled it
73.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00160108 phase1completednot on this map

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

TypeinterventionalSponsorThe S. Daniel Abraham International Center for Health and NutritionRan2005 to 2007Enrolled300ConditionsObesity, CHDArmsdietary intervention
NCT00725257 nacompletednot on this map

Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients

TypeinterventionalSponsorUniversity of Campania Luigi VanvitelliRan2004 to 2007Enrolled215ConditionsType 2 Diabetes MellitusArmsMediterranean diet, Low-fat diet
NCT01530724 phase3completednot on this mapstarted 2012, after this paper: background citation

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

TypeinterventionalSponsorBen-Gurion University of the NegevRan2012 to 2014Enrolled224ConditionsObesityArmsWeight-loss diet strategy (+) exercise (PA), weight loss (-) exercise (PA)
NCT02078635 nawithdrawnnot on this map

The Canada-wide Human Nutrition Trialists' Network

TypeinterventionalSponsorUnity Health TorontoEnrolled0ConditionsCardiovascular Diseases, Hypercholesterolemia, Diabetes, Metabolic SyndromeArmsPortfolio Plus Diet, DASH-like (high fibre) dietary advice
NCT02245399 nacompletednot on this mapstarted 2014, after this paper: background citation

Canola Enriched Mediterranean Type Weight Loss Diet in Type 2 Diabetes

TypeinterventionalSponsorUnity Health TorontoRan2014 to 2017Enrolled164ConditionsType 2 Diabetes, Obesity, Overweight, Cardiovascular DiseasesArmsA canola oil enriched mediterranean diet, A high wheat fiber diet
NCT02481466 nacompletednot on this mapstarted 2016, after this paper: background citation

The First Cross-Canada Trial of the Nutrition Trialists' Network--Enhanced Dietary Portfolio and Exercise on Arterial Damage (MRI-Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk)

TypeinterventionalSponsorUnity Health TorontoRan2016 to 2023Enrolled232ConditionsCardiovascular Diseases, Hypercholesterolemia, Type 2 Diabetes, Metabolic SyndromeArmsPortfolio diet and structured exercise, DASH-like diet and structured exercise, Portfolio diet and routine exercise, DASH-like diet and routine exercise
NCT02923453 phase2completednot on this map

Efficacy and Safety of American Ginseng (Penax Quinquefolius) Extract on Glycemic Control in Individuals With Type 2 Diabetes: A Double-blind, Randomized, Crossover Clinical Trial

TypeinterventionalSponsorUnity Health TorontoRan1998 to 2002Enrolled23ConditionsType II Diabetes ControlArmsCNT 2000 American ginseng extract, Placebo
NCT03372109 nacompletednot on this mapstarted 2017, after this paper: background citation

A Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period

TypeinterventionalSponsorSupplement Formulators, Inc.Ran2017 to 2018Enrolled23ConditionsBody Weight ChangesArmsMeal replacement shake, Multivitamin and mineral capsules, Fish oil with sesame lignans and olive extract softgel, Prebiotic Chewable tablet, Clove Extract and Maqui Berry extract capsule
NCT05163743 naunknown statusnot on this mapstarted 2021, after this paper: background citation

COVID-19 Vaccination in Subjects With Obesity: Impact of Metabolic Health and the Role of a Ketogenic Diet

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2021 to 2021Enrolled24ConditionsObesityArmsLow Calorie Ketogenic Diet
NCT07017127 narecruitingnot on this mapstarted 2025, after this paper: background citation

Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial

TypeinterventionalSponsorUniversity of Split, School of MedicineRan2025 to 2027Enrolled120ConditionsDiabetes Mellitus Type 2, Obese DiabeticsArmsMediterranean diet, Physical activity intervention, Psychological intervention
3 · Its place in the literature

Who cites it

752 citing papers in PubMed, 23 syntheses or guidelines pooled it, 2,111 citations in OpenAlex.

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  15. Obesity in South and Southeast Asia-A new consensus on care and management.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2023
    Guideline
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  20. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline

692 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 5 institutions in 3 countries.

Iris ShaiS. Daniel Abraham Center for Health and Nutrition, Ben-Gurion University of the Negev, Beer-Sheva, Israel. irish@bgu.ac.il
Dan Schwarzfuchs
Yaakov Henkin
Danit R Shahar
Shula Witkow
Ilana Greenberg
Rachel Golan
Drora Fraser
Arkady Bolotin
Hilel Vardi
Osnat Tangi-Rozental
Rachel Zuk-Ramot
Benjamin Sarusi
Dov Brickner
Ziva Schwartz
Einat Sheiner
Rachel Marko
Esther Katorza
Joachim Thiery
Georg Martin Fiedler
Matthias Blüher
Michael Stumvoll
Meir J Stampfer
Dietary Intervention Randomized Controlled Trial (DIRECT) Group
Ben-Gurion University of the Negev · ILLeipzig University · DEUniversity Hospital Leipzig · DEHarvard University · USUniversity Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrials comparing the effectiveness and safety of weight-loss diets are frequently limited by short follow-up times and high dropout rates.

methodsIn this 2-year trial, we randomly assigned 322 moderately obese subjects (mean age, 52 years; mean body-mass index [the weight in kilograms divided by the square of the height in meters], 31; male sex, 86%) to one of three diets: low-fat, restricted-calorie; Mediterranean, restricted-calorie; or low-carbohydrate, non-restricted-calorie.

resultsThe rate of adherence to a study diet was 95.4% at 1 year and 84.6% at 2 years. The Mediterranean-diet group consumed the largest amounts of dietary fiber and had the highest ratio of monounsaturated to saturated fat (P<0.05 for all comparisons among treatment groups). The low-carbohydrate group consumed the smallest amount of carbohydrates and the largest amounts of fat, protein, and cholesterol and had the highest percentage of participants with detectable urinary ketones (P<0.05 for all comparisons among treatment groups). The mean weight loss was 2.9 kg for the low-fat group, 4.4 kg for the Mediterranean-diet group, and 4.7 kg for the low-carbohydrate group (P<0.001 for the interaction between diet group and time); among the 272 participants who completed the intervention, the mean weight losses were 3.3 kg, 4.6 kg, and 5.5 kg, respectively. The relative reduction in the ratio of total cholesterol to high-density lipoprotein cholesterol was 20% in the low-carbohydrate group and 12% in the low-fat group (P=0.01). Among the 36 subjects with diabetes, changes in fasting plasma glucose and insulin levels were more favorable among those assigned to the Mediterranean diet than among those assigned to the low-fat diet (P<0.001 for the interaction among diabetes and Mediterranean diet and time with respect to fasting glucose levels).

conclusionsMediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions. (ClinicalTrials.gov number, NCT00160108.)

Indexed as

Diet, Carbohydrate-RestrictedDiet, Fat-RestrictedDiet, MediterraneanBiomarkersBlood GlucoseBody Mass IndexEnergy IntakeFemaleFollow-Up StudiesGlycated HemoglobinHumansKetonesLipidsMaleMiddle AgedObesityBiomarkersBlood GlucoseGlycated HemoglobinKetonesLipids

Identifiers

PMID18635428
OpenAlexW2146463166

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 4 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.