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

• Published in: BMC medicine Vol. 20; no. 1; pp. 56 - 13
• Main Authors: Rein, Michal, Ben-Yacov, Orly, Godneva, Anastasia, Shilo, Smadar, Zmora, Niv, Kolobkov, Dmitry, Cohen-Dolev, Noa, Wolf, Bat-Chen, Kosower, Noa, Lotan-Pompan, Maya, Weinberger, Adina, Halpern, Zamir, Zelber-Sagi, Shira, Elinav, Eran, Segal, Eran
• Format: Journal Article
• Language: English
• Published: London BioMed Central 09.02.2022; BioMed Central Ltd; BMC
• Subjects: Adult; Algorithms; Analysis; Biomedicine; Blood Glucose - metabolism; Blood Glucose Self-Monitoring; Blood sugar monitoring; Carbohydrates; Care and treatment; Clinical medicine; Complications; Customization; Dairy products; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - diagnosis; Diagnosis; Diet; Diet, Mediterranean; Dietary intake; Dietary intervention; Evaluation; Female; Food; Food intake; Glucose; Glucose monitoring; Glycemic Control; Glycemic index; Glycosylated hemoglobin; Gut microbiome; Hemoglobin; Humans; Intervention; Intestinal microflora; Learning algorithms; Long-term effects; Machine learning; Male; Meals; Medical diagnosis; Medicine; Medicine & Public Health; Metabolism; Methods; Microbiomes; Middle Aged; Nutrition research; Parameters; Personalized nutrition; Pilot Projects; Postprandial glucose responses; Questionnaires; Remission; Research Article; Risk factors; Triglycerides; Type 2 diabetes; Type 2 diabetes mellitus; Israel; Personalized nutrition; Dietary intervention; Type 2 diabetes mellitus; Gut microbiome; Postprandial glucose responses
• ISSN: 1741-7015; 1741-7015
• DOI: 10.1186/s12916-022-02254-y

Background 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. Methods 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. Results 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. Conclusion 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. Trial registration ClinicalTrials.gov number, NCT01892956