Randomized controlled trial2021Industry fundedOpen access

Funded in part by California Walnut Commission, California Walnuts Commission

Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial

Yaskolka Meir A, Rinott E, Tsaban G, Zelicha H, Kaplan A, Rosen P, Shelef I, Youngster I, Shalev A, Blüher M, Ceglarek U, Stumvoll M, Tuohy K, Diotallevi C, Vrhovsek U, Hu F, Stampfer M, Shai I

Gut · 210 citations

Review labels

Author industry tiesIndustry fundedLumps processed with unprocessed meat

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function
Intake measured by
Not stated

Who paid for it

Funding
Industry funded
Government
Joint Programming Initiative A healthy diet for a healthy life
Industry group
California Walnut Commission
Government
European Commission
Government
Deutsche Forschungsgemeinschaft
University or hospital
Ben-Gurion University of the Negev
Government
ERA-Net Cofund ERA-HDHL “Biomarkers for Nutrition and Health implementing the JPI HDHL objectives”
Government
European Union’s Horizon2020 research and innovation
Government
Israel Ministry of Science and Technology
Government
the Deutsche Forschungsgemeinschaft
Industry group
California Walnuts Commission
Government
Israel Ministry of Health
Authors
At least one author declares a financial tie to industry
Grants
Deutsche Forschungsgemeinschaft (SFB 1052); Deutsche Forschungsgemeinschaft (209933838); California Walnut Commission (87472511); European Commission (696295); Deutsche Forschungsgemeinschaft (SFB-1052/B11); California Walnut Commission (209933838); Deutsche Forschungsgemeinschaft (grant SFB1052); California Walnut Commission (SFB-1052/B11); Deutsche Forschungsgemeinschaft (87472511); Joint Programming Initiative A healthy diet for a healthy life (696295); California Walnut Commission (3-13604); Deutsche Forschungsgemeinschaft (3-13604); California Walnut Commission (SFB1052); European Commission (209933838)

Based on 11 listed funder(s) and full-text disclosure statement.

Publication

Published
2021-01-18 · Gut · vol. 70 · issue 11 · pp. 2085–2095
Publisher
BMJ
Cited
284 citations · more than 100% of similar papers · 25.9× the field average
Impact
Top 10% most cited in its field
References
52 works
Access
Open access (hybrid journal) · CC-BY-NC
Research areas
Agriculture Sustainability and Environmental Impact · Nutritional Studies and Diet · Animal Nutrition and Physiology
Keywords
Fatty liver, Weight loss, Medicine, Animal science, Obesity, Internal medicine, Polyphenol, Body mass index, Gastroenterology, Surgery, Biology, Disease, Biochemistry, Antioxidant
MeSH
humans, araceae, diet, reducing, diet, mediterranean, tea, middle aged, female, male, polyphenols, non-alcoholic fatty liver disease

18 authors

From IL, DE, IT, US

  • Anat Yaskolka MeirBen-Gurion University of the Negev
  • Ehud RinottBen-Gurion University of the Negev
  • Gal TsabanBen-Gurion University of the Negev; Soroka Medical Center
  • Hila ZelichaBen-Gurion University of the Negev
  • Alon KaplanBen-Gurion University of the Negev
  • Philip RosenSoroka Medical Center

Abstract

Objective

To examine the effectiveness of green-Mediterranean (MED) diet, further restricted in red/processed meat, and enriched with green plants and polyphenols on non-alcoholic fatty liver disease (NAFLD), reflected by intrahepatic fat (IHF) loss.

Design

For the DIRECT-PLUS 18-month randomized clinical trial, we assigned 294 participants with abdominal obesity/dyslipidaemia into healthy dietary guidelines (HDG), MED and green-MED weight-loss diet groups, all accompanied by physical activity. Both isocaloric MED groups consumed 28 g/day walnuts (+440 mg/day polyphenols provided). The green-MED group further consumed green tea (3-4 cups/day) and Mankai (a Wolffia globosa aquatic plant strain; 100 g/day frozen cubes) green shake (+1240 mg/day total polyphenols provided). IHF% 18-month changes were quantified continuously by proton magnetic resonance spectroscopy (MRS).

Results

Participants (age=51 years; 88% men; body mass index=31.3 kg/m2; median IHF%=6.6%; mean=10.2%; 62% with NAFLD) had 89.8% 18-month retention-rate, and 78% had eligible follow-up MRS. Overall, NAFLD prevalence declined to: 54.8% (HDG), 47.9% (MED) and 31.5% (green-MED), p=0.012 between groups. Despite similar moderate weight-loss in both MED groups, green-MED group achieved almost double IHF% loss (-38.9% proportionally), as compared with MED (-19.6% proportionally; p=0.035 weight loss adjusted) and HDG (-12.2% proportionally; pNaringenin and 2-5-dihydroxybenzoic-acid in green-MED. Greater IHF% loss was independently associated with increased Mankai and walnuts intake, decreased red/processed meat consumption, improved serum folate and adipokines/lipids biomarkers, changes in microbiome composition (beta-diversity) and specific bacteria (p<0.05 for all).

Conclusion

The new suggested strategy of green-Mediterranean diet, amplified with green plant-based proteins/polyphenols as Mankai, green tea, and walnuts, and restricted in red/processed meat can double IHF loss than other healthy nutritional strategies and reduce NAFLD in half.

Trial registration number

NCT03020186.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).

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