Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial
Open accessAbstract
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/m 2 ; 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; p<0.001). After 18 months, both MED groups had significantly higher total plasma polyphenol levels versus HDG, with higher detection of Naringenin 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 .
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Only a few studies have performed 12-24 month follow-ups, showing a maximal weight loss at 6 months, followed by a gradual weight regain to a net weight loss of about 5% at 12-24 months and partial regain of liver lipid content and stiffness.
“Only a few studies have performed 1224monthfollow-ups,showingamaximal weightloss at6 months, followed by a gradual weight regain to a net weight loss of about 5% at 12-24 months and partial regain of liver lipid content and stiffness. 286 -288”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [287]
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Experimental — accuracy not yet measuredThe Mediterranean diet seems to have added value for liver lipid reduction and cardiometabolic health and may be easier to maintain in the long-term.
“However, the Mediterranean diet seems to have added value for liver lipid reduction and cardiometabolic health and may be easier to maintain in the long-term. 285,287”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [287]
The Results report reduced intrahepatic fat after 18 months in both Mediterranean-diet groups, and the Introduction says the diet improves cardiometabolic biomarkers. The Results’ adherence section reports high retention but no significant difference in dropout between groups; it does not establish that the diet is easier to maintain long-term. (LLM, conf=0.87)
Experimental — accuracy not yet measuredMediterranean diets showed beneficial effects on liver lipid content and non-invasive markers of MASLD, but also on type 2 diabetes and cardiovascular outcomes.
“Besides macronutrient composition, overall healthy eating behavior may be relevant, as Mediterranean diets showed beneficial effects on liver lipid content and non-invasive markers of MASLD [62,63], but also on type 2 diabetes [64] and cardiovascular outcomes [65].”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [63]
In a randomized control trial, a Mediterranean diet enriched in green plants with reduced red meat intake enhanced intrahepatic fat loss compared to the control diet, proving beneficial effects of the Mediterranean diet on reducing hepatic steatosis.
“In a randomized control trial (RCT), Yaskolka et al. were able to demonstrate that an MD enriched in green plants with reduced red meat intake was able to enhance intrahepatic fat loss in comparison to the control diet, proving the beneficial effects of MD on reducing hepatic steatosis [37].”
From Mediterranean Diet as an Antioxidant: The Impact on Metabolic Health and Overall Wellbeing (2021) · cites this paper as [37]
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- Authors
- 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.
- Affiliations
- Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel
- Ben-Gurion University of the Negev (IL)
- Soroka Medical Center (IL)
- Assaf Harofeh Medical Center (IL)
- Division of Cardiology, Soroka Medical Center, Beer Sheva, Israel
- Leipzig University (DE)
- Medical Department III – Endocrinology, Nephrology, Rheumatology, Leipzig University, Leipzig, Germany
- Fondazione Edmund Mach (IT)
- Faculty of Science and Technology, Free University of Bozen-Bolzano, Bolzano, Italy
- Brigham and Women's Hospital (US)
- Corresponding author
- Shai, Iris
- ORCID
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2021-01-18
- Volume
- 70
- Issue
- 11
- Pages
- 2085-2095
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- PMC
- PMC8515100
- OpenAlex
- W3122227207
- Cited by
- 287
- References
- 48
- Citations by year
- 2026: 54 · 2025: 63 · 2024: 47 · 2023: 54 · 2022: 46 · 2021: 23
- FWCI
- 30.59
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Gut (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- CINECA IRIS Institutional Research Information System (Fondazione Edmund Mach) (submittedVersion, cc-by-nc)
- Open Research (University of Surrey) (submittedVersion, other-oa)
- Funders
- European Union’s Horizon2020 research and innovation (grant agreement No 696295)
- California Walnuts Commission (NA)
- the Deutsche Forschungsgemeinschaft (project no. 209933838, grant SFB1052)
- ERA-Net Cofund ERA-HDHL “Biomarkers for Nutrition and Health implementing the JPI HDHL objectives” (NA)
- Israel Ministry of Science and Technology (3-13604)
- Israel Ministry of Health (grant 87472511)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diet, Metabolism, and Disease
- Keywords
- non-alcoholic fatty liver disease, intrahepatic fat, abdominal obesity, dyslipidemia, Juglans regia, Wolffia globosa, green tea, polyphenols, dietary weight loss, gut microbiota, naringenin, folic acid, adipokines, 1H NMR
- MeSH terms
- Diet, Reducing, Female, Humans, Male, Middle Aged, Tea, Araceae, Diet, Mediterranean, Polyphenols, Non-alcoholic Fatty Liver Disease
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