A randomized clinical trial comparing low-fat with precision nutrition-based diets for weight loss: impact on glycemic variability and HbA1c.

Eran Segal, Anna Y Kharmats, Collin Popp, Lu Hu, Lauren Berube, Margaret Curran, Chan Wang, Mary Lou Pompeii, Huilin Li, Michael Bergman, David E St-Jules, Antoinette Schoenthaler, Natasha Williams, Ann Marie Schmidt, Souptik Barua, Mary Ann Sevick

Journal: The American journal of clinical nutrition 2023;118(2):443-451

PMID: 37236549

Plain Language Summary

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Elevated postprandial glucose response (PPGR) increases oxidative damage and is an independent risk factor for the development of various health conditions. Conventional dietary strategies for minimizing PPGR are based on limiting the glycemic load of meals and snacks by moderating the intake of carbohydrates with low-carbohydrate or ketogenic diets and promoting whole plant foods that contain soluble dietary fibre. The aim of this study was to compare changes in glycaemic variability (GV) and HbA1c in two calorie-restricted weight loss diets. This study was a randomised clinical trial called the Personal Diet Study. Participants were randomly assigned to either the standardised low-fat diet or the personalised diet. Results showed that the personalised precision nutrition algorithm-designed weight loss diet did not significantly differ from the standardised weight-loss diet in terms of HbA1c or glycemic variability values. Both diets had similar effects on these outcomes. Authors concluded that in adults with pre-diabetes or moderately controlled type 2 diabetes, personalised precision nutrition did not show superior results compared to the standardised low-fat diet in terms of glycaemic control and variability.

Abstract

BACKGROUND

Recent studies have demonstrated considerable interindividual variability in postprandial glucose response (PPGR) to the same foods, suggesting the need for more precise methods for predicting and controlling PPGR. In the Personal Nutrition Project, the investigators tested a precision nutrition algorithm for predicting an individual's PPGR.

OBJECTIVE

This study aimed to compare changes in glycemic variability (GV) and HbA1c in 2 calorie-restricted weight loss diets in adults with prediabetes or moderately controlled type 2 diabetes (T2D), which were tertiary outcomes of the Personal Diet Study.

METHODS

The Personal Diet Study was a randomized clinical trial to compare a 1-size-fits-all low-fat diet (hereafter, standardized) with a personalized diet (hereafter, personalized). Both groups received behavioral weight loss counseling and were instructed to self-monitor diets using a smartphone application. The personalized arm received personalized feedback through the application to reduce their PPGR. Continuous glucose monitoring (CGM) data were collected at baseline, 3 mo and 6 mo. Changes in mean amplitude of glycemic excursions (MAGEs) and HbA1c at 6 mo were assessed. We performed an intention-to-treat analysis using linear mixed regressions.

RESULTS

We included 156 participants [66.5% women, 55.7% White, 24.1% Black, mean age 59.1 y (standard deviation (SD) = 10.7 y)] in these analyses (standardized = 75, personalized = 81). MAGE decreased by 0.83 mg/dL per month for standardized (95% CI: 0.21, 1.46 mg/dL; P = 0.009) and 0.79 mg/dL per month for personalized (95% CI: 0.19, 1.39 mg/dL; P = 0.010) diet, with no between-group differences (P = 0.92). Trends were similar for HbA1c values.

CONCLUSIONS

Personalized diet did not result in an increased reduction in GV or HbA1c in patients with prediabetes and moderately controlled T2D, compared with a standardized diet. Additional subgroup analyses may help to identify patients who are more likely to benefit from this personalized intervention. This trial was registered at clinicaltrials.gov as NCT03336411.

Copyright © 2023 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.

Address: Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, New York, NY, United States; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States.; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, New York, NY, United States; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States. Electronic address: [email protected].; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States.; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States; Division of Endocrinology, Diabetes and Metabolism, New York University Grossman School of Medicine, New York, NY, United States.; Department of Nutrition, University of Nevada, Reno, Reno, NV, United States.; Department of Computer Science and Applied Math, Weizmann Institute of Science, Rehovot, Israel.; Diabetes Research Program, Department of Medicine, New York University Langone Health, New York, NY, United States.; Division of Precision Medicine, Department of Medicine, New York University Langone Health, New York, NY, United States.; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, New York, NY, United States; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States; Division of Endocrinology, Diabetes and Metabolism, New York University Grossman School of Medicine, New York, NY, United States.

Patient Centred Factor

Clinical Imbalances

Laboratory Testing

Modifiable Lifestyle Factors

Jadad Score

Allocation Concealment

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