PMID- 35641199 OWN - NLM STAT- MEDLINE DCOM- 20220908 LR - 20240214 IS - 1938-3207 (Electronic) IS - 0002-9165 (Print) IS - 0002-9165 (Linking) VI - 116 IP - 3 DP - 2022 Sep 2 TI - Effect of a ketogenic diet versus Mediterranean diet on glycated hemoglobin in individuals with prediabetes and type 2 diabetes mellitus: The interventional Keto-Med randomized crossover trial. PG - 640-652 LID - 10.1093/ajcn/nqac154 [doi] AB - BACKGROUND: Consensus has not been reached on what constitutes an optimal diet in individuals with prediabetes and type 2 diabetes mellitus (T2DM), especially between low-carbohydrate options. OBJECTIVES: We compared 2 low-carbohydrate diets with 3 key similarities (incorporating nonstarchy vegetables and avoiding added sugars and refined grains) and 3 key differences (incorporating compared with avoiding legumes, fruits, and whole, intact grains) for their effects on glucose control and cardiometabolic risk factors in individuals with prediabetes and T2DM. METHODS: Keto-Med was a randomized, crossover, interventional trial. Forty participants aged >/=18 years with prediabetes or T2DM followed the well-formulated ketogenic diet (WFKD) and the Mediterranean-plus diet (Med-Plus) for 12 weeks each, in random order. The diets shared the 3 key similarities noted above. The Med-Plus incorporated legumes, fruits, and whole, intact grains, while the WFKD avoided them. The primary outcome was the percentage change in glycated hemoglobin (HbA1c) after 12 weeks on each diet. Secondary and exploratory outcomes included percentage changes in body weight, fasting insulin, glucose, and blood lipids; average glucose from continuous glucose monitor (CGM), and nutrient intake. RESULTS: The primary analysis was of 33 participants with complete data. The HbA1c values did not differ between diets at 12 weeks. Triglycerides decreased more for the WFKD [percentage changes, -16% (SEM, 4%) compared with -5% (SEM, 6%) for the Med-Plus; P = 0.02] and LDL cholesterol was higher for the WFKD [percentage changes, +10% (SEM, 4%) compared with -5% (SEM, 5%) for the Med-Plus; P = 0.01]. Weight decreased 8% (SEM, 1%) compared with 7% (SEM, 1%) and HDL cholesterol increased 11% (SEM, 2%) compared with 7% (SEM, 3%) for the WFKD compared with the Med-Plus, respectively; however, there was a significant interaction of diet x order for both. Participants had lower intakes of fiber and 3 nutrients on the WFKD compared with the Med-Plus. Twelve-week follow-up data suggest the Med-Plus is more sustainable. CONCLUSIONS: HbA1c values were not different between diet phases after 12 weeks, but improved from baseline on both diets, likely due to several shared dietary aspects. The WFKD led to a greater decrease in triglycerides, but also had potential untoward risks from elevated LDL cholesterol and lower nutrient intakes from avoiding legumes, fruits, and whole, intact grains, as well as being less sustainable. This trial was registered at clinicaltrials.gov as NCT03810378. CI - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition. FAU - Gardner, Christopher D AU - Gardner CD AUID- ORCID: 0000-0002-7596-1530 AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Landry, Matthew J AU - Landry MJ AUID- ORCID: 0000-0003-2285-7702 AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Perelman, Dalia AU - Perelman D AUID- ORCID: 0000-0003-3335-1950 AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Petlura, Christina AU - Petlura C AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Durand, Lindsay R AU - Durand LR AUID- ORCID: 0000-0002-6188-3308 AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Aronica, Lucia AU - Aronica L AUID- ORCID: 0000-0002-8991-4858 AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Crimarco, Anthony AU - Crimarco A AUID- ORCID: 0000-0002-4553-4589 AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Cunanan, Kristen M AU - Cunanan KM AD - Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA, USA. FAU - Chang, Annie AU - Chang A AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Dant, Christopher C AU - Dant CC AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Robinson, Jennifer L AU - Robinson JL AD - Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA. FAU - Kim, Sun H AU - Kim SH AUID- ORCID: 0000-0003-0895-7491 AD - Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University Medical Center, Stanford, CA, USA. LA - eng SI - ClinicalTrials.gov/NCT03810378 GR - T32 HL007034/HL/NHLBI NIH HHS/United States GR - UL1 TR001085/TR/NCATS NIH HHS/United States GR - P30 DK020579/DK/NIDDK NIH HHS/United States GR - P30 DK116074/DK/NIDDK NIH HHS/United States GR - UL1 TR003142/TR/NCATS NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - Am J Clin Nutr JT - The American journal of clinical nutrition JID - 0376027 RN - 0 (Blood Glucose) RN - 0 (Cholesterol, LDL) RN - 0 (Glycated Hemoglobin A) RN - 0 (Triglycerides) SB - IM CIN - Am J Clin Nutr. 2022 Oct 6;116(4):1184. PMID: 35976052 EIN - Am J Clin Nutr. 2022 Dec 19;116(6):1904. PMID: 36349565 MH - Adolescent MH - Adult MH - Blood Glucose MH - Cholesterol, LDL MH - Cross-Over Studies MH - *Diabetes Mellitus, Type 2 MH - *Diet, Ketogenic MH - *Diet, Mediterranean MH - Glycated Hemoglobin/analysis MH - Humans MH - *Prediabetic State MH - Triglycerides MH - Vegetables PMC - PMC9437985 OTO - NOTNLM OT - HbA1c OT - Mediterranean OT - diabetes OT - diet OT - human OT - intervention OT - ketogenic OT - metabolomic OT - prediabetes EDAT- 2022/06/01 06:00 MHDA- 2022/09/09 06:00 PMCR- 2022/05/31 CRDT- 2022/05/31 21:24 PHST- 2021/12/18 00:00 [received] PHST- 2022/03/09 00:00 [revised] PHST- 2022/05/25 00:00 [accepted] PHST- 2022/06/01 06:00 [pubmed] PHST- 2022/09/09 06:00 [medline] PHST- 2022/05/31 21:24 [entrez] PHST- 2022/05/31 00:00 [pmc-release] AID - S0002-9165(22)00081-8 [pii] AID - nqac154 [pii] AID - 10.1093/ajcn/nqac154 [doi] PST - ppublish SO - Am J Clin Nutr. 2022 Sep 2;116(3):640-652. doi: 10.1093/ajcn/nqac154.