Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Rein M

PROVIDER: S-EPMC8826661 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

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.

Rein Michal M Ben-Yacov Orly O Godneva Anastasia A Shilo Smadar S Zmora Niv N Kolobkov Dmitry D Cohen-Dolev Noa N Wolf Bat-Chen BC Kosower Noa N Lotan-Pompan Maya M Weinberger Adina A Halpern Zamir Z Zelber-Sagi Shira S Elinav Eran E Segal Eran E

BMC medicine 20220209 1

<h4>Background</h4>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.<h4>Methods</h4>We enrolled 23 ...[more]

PMID: 35135549

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Project description:BackgroundIndividuals who are newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) may choose not to undergo disease-modifying therapies (DMTs) due to concerns about expenses or potential adverse effects. Thus, many individuals will opt for alternative therapies, such as dietary modifications. Among these dietary approaches, the modified Paleolithic elimination diet has shown promise for improving MS-related symptoms; however, restriction of certain food groups can lead to inadequate intake of nutrients.MethodsThree-day self-reported 24-h dietary recalls using the Automated Self-Administered 24-h (ASA24) Dietary Assessment Tool were assessed during a 12-month quasi-experimental (i.e., non-randomized) trial among individuals who either voluntarily declined DMTs and received health behavior (HB) intervention, (n = 29) or included DMTs and opted for the standard of care (SOC; n = 15). Participants in the HB group received a multimodal intervention that included dietary modifications, a walking program, and breathing exercises. Usual intake of each micronutrient was estimated and then evaluated with the estimated average requirement (EAR)-cut point method.ResultsAt 12 months, >80% of both HB and SOC groups completed 3 days of the self-reported 24-h recalls, indicating the potential feasibility of ASA24. From baseline to 12 months, the HB group had a decreased mean ratio in total grains (0.64; 95% CI 0.43-0.93; p = 0.02) and added sugars (0.52; 95% CI 0.35-0.75; p ≤ 0.001), and an increased mean ratio intake of cured meats (1.74; 95% CI 1.05-2.90; p = 0.04); whereas, the SOC group had a decreased mean ratio intake for beef, veal, pork, lamb, and game meat (0.60; 95% CI 0.40-0.90; p = 0.01). At baseline, both groups had high proportions with inadequate intake of vitamin E and calcium. The SOC group also had a high proportion with inadequate intake of vitamin D. By 12-months, the HB group exhibited severe proportions of nutrient inadequacies (>20% of the group) for vitamin D (43.5%), vitamin E (29.1%), calcium (69.9%), and copper (27.8%). The SOC group, following their own diet, had inadequacies for all the same micronutrients, except for copper, as the HB group. The SOC group also had additional inadequacies: vitamin A (21.3%), thiamin (26.3%), riboflavin (24.2%), folate (24.8%), vitamin B12 (27.8%), and zinc (28.2%).ConclusionCompared to the usual diet, adhering to the modified Paleolithic elimination diet, as a component of a 12-month multimodal intervention, may lead to reduced consumption of specific food groups, such as added sugars, as well as decreased risk of severe proportions of inadequacy for certain nutrients. The utilization of the ASA24 for acquiring dietary recalls from participants with MS may be feasible for future studies.Clinical trial registrationclinicaltrials.gov identifier NCT04009005.

Dataset Information

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.

Background

Methods

Results

Conclusion

Trial registration

Publications

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.

Similar Datasets

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