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Journal article
Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial
BMC medicine, Vol.20, 56
09/Feb/2022
PMID: 35135549
Abstract
Dietary modifications are crucial for managing newly diagnosed type 2 diabetes mellitus (T2DM) and preventing its health complications, but many patients fail to achieve clinical goals with diet alone. We sought to evaluate the clinical effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in individuals with newly diagnosed T2DM as compared to the commonly recommended Mediterranean-style (MED) diet.
We enrolled 23 adults with newly diagnosed T2DM (aged 53.5 ± 8.9 years, 48% males) for a randomized crossover trial of two 2-week-long dietary interventions. Participants were blinded to their assignment to one of the two sequence groups: either PPT-MED or MED-PPT diets. The PPT diet relies on a machine learning algorithm that integrates clinical and microbiome features to predict personal postprandial glucose responses (PPGR). We further evaluated the long-term effects of PPT diet on glycemic control and metabolic health by an additional 6-month PPT intervention (n = 16). Participants were connected to continuous glucose monitoring (CGM) throughout the study and self-recorded dietary intake using a smartphone application.
In the crossover intervention, the PPT diet lead to significant lower levels of CGM-based measures as compared to the MED diet, including average PPGR (mean difference between diets, - 19.8 ± 16.3 mg/dl × h, p < 0.001), mean glucose (mean difference between diets, - 7.8 ± 5.5 mg/dl, p < 0.001), and daily time of glucose levels > 140 mg/dl (mean difference between diets, - 2.42 ± 1.7 h/day, p < 0.001). Blood fructosamine also decreased significantly more during PPT compared to MED intervention (mean change difference between diets, - 16.4 ± 37 μmol/dl, p < 0.0001). At the end of 6 months, the PPT intervention leads to significant improvements in multiple metabolic health parameters, among them HbA1c (mean ± SD, - 0.39 ± 0.48%, p < 0.001), fasting glucose (- 16.4 ± 24.2 mg/dl, p = 0.02) and triglycerides (- 49 ± 46 mg/dl, p < 0.001). Importantly, 61% of the participants exhibited diabetes remission, as measured by HbA1c < 6.5%. Finally, some clinical improvements were significantly associated with gut microbiome changes per person.
In this crossover trial in subjects with newly diagnosed T2DM, a PPT diet improved CGM-based glycemic measures significantly more than a Mediterranean-style MED diet. Additional 6-month PPT intervention further improved glycemic control and metabolic health parameters, supporting the clinical efficacy of this approach.
ClinicalTrials.gov number, NCT01892956.
Details
- Title
- Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial
- Creators
- Michal Rein - 972WIS_INST___83Orly Ben-Yacov - 972WIS_INST___83Anastasia Godneva - 972WIS_INST___83Smadar Shilo - 972WIS_INST___83Niv Zmora - Tel Aviv Sourasky Medical CenterDmitry Kolobkov - 972WIS_INST___83Noa Cohen-Dolev - 972WIS_INST___83Bat-Chen Wolf - 972WIS_INST___83Noa Kosower - 972WIS_INST___83Maya Lotan-Pompan - 972WIS_INST___83Adina Weinberger - 972WIS_INST___83Zamir Halpern - Tel Aviv Sourasky Medical CenterShira Zelber-Sagi - University of HaifaEran Elinav - 972WIS_INST___121Eran Segal - 972WIS_INST___83
- Resource Type
- Journal article
- Publication Details
- BMC medicine, Vol.20, 56; 09/Feb/2022
- Number of pages
- 13
- Language
- English
- DOI
- https://doi.org/10.1186/s12916-022-02254-y
- PMID
- 35135549
- Grant note
- We thank the Segal group members for the fruitful discussions. David Zeevi, Ph.D., and Tal Korem, Ph.D.; former lab members; and Ofra Lavi, from AMC Medical Center Laboratory, Rishon-LeZion, Israel, for operating all the processes of blood tests at the central laboratory of the trial, and Rachel Segall, for coordinating collaboration with AMC Medical Center Laboratory. Funding The funding for the study was provided by the DayTwo Company. E.S. and E.E. are paid scientific consultants for DayTwo Inc. No pharmaceutical manufacturers or other companies from the industry contributed to the planning, design, or conduct of the trial. The analyses presented here were performed by Weizmann scientists independent of the sponsors. The scientists have the right to publish regardless of the outcome. No other potential conflicts of interest relevant to this article were reported. Contributions MR, OBY, AG, and AW conceived the study and designed the intervention. MR, OBY, and AG directed the project conduct and data collection and equally contributed to the study. MR and OBY were the clinical trial leads, oversaw the conduct of the study, and wrote the manuscript. AG directed all computational aspects of the study, with support from DK. SS and NZ were the medical leads of the study. MR, OBY, and NCD provided dietary recommendations and personal dietetic support throughout the intervention to all study participants. BW and NK coordinated participants’ recruitment and management throughout the intervention and follow-up. AW developed the protocols and directed and performed the microbiome sample sequencing with support from MLP. MR, OBY, and AG designed and conducted the analyses and interpreted the results. SZS was involved in the study design, interpreted the results, and wrote the manuscript. ES and EE conceived and directed the project and analyses, designed the analyses, interpreted the results, and wrote the manuscript. All authors read and approved the final manuscript.
- Record Identifier
- 993346548503596
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