Abstract
Lifestyle modification, including nutrition therapy, plays an important role in diabetes management. The objective of this randomized controlled trial was to investigate the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in individuals with type 2 diabetes. A total of 251 adult men and women with type 2 diabetes on oral anti-hyperglycemic medication(s) were enrolled, and 235 were randomly assigned to one of two study treatments: (i) DSF with standard of care (DSF group) (n = 117) or (ii) standard of care alone (control group) (n = 118). The DSF group was asked to consume either one serving of DSF (if baseline BMI ≥ 23.0 and <27.5 kg/m2) or two servings of DSF (if baseline BMI ≥ 27.5 and <35.0 kg/m2) as a meal replacement (MR) or partial MR. Blood biomarkers, anthropometry, body composition, and blood pressure were assessed at baseline, day 45, and day 90. Mean (SE) HbA1c of participants was 7.94 (0.05)% and BMI was 28.37 (0.21) kg/m2 at baseline. The DSF group had a significantly greater reduction in HbA1c than the control group at day 45 (−0.44% vs. −0.26%; p = 0.015) and day 90 (−0.50% vs. −0.21%; p = 0.002). Fasting blood glucose was significantly lower in the DSF group at Day 90 (−0.14 mmol/L vs. +0.32 mmol/L; p = 0.036). The DSF group lost twice as much weight as the control group at day 45 (−1.30 kg vs. −0.61 kg; p < 0.001) and day 90 (−1.74 kg vs. −0.76 kg; p < 0.001). Waist circumference, hip circumference, fat mass, and visceral adipose tissue were significantly lower in the DSF group compared to the control group (all overall p ≤ 0.004). The DSF group also had significantly lower diastolic blood pressure (overall p = 0.045) and systolic blood pressure at day 90 (p = 0.043). This study demonstrated that consuming DSF as a MR or partial MR in addition to the standard of care resulted in significantly greater improvements in glycemic control and cardiometabolic risk factors in overweight and obese adults with type 2 diabetes compared to the standard of care alone.
Author Contributions
Conceptualization, S.L.T. and D.T.T.H.; methodology, S.L.T., G.B. and D.T.T.H.; formal analysis, Y.B., G.B. and S.L.T.; investigation, W.S.S.C.; data curation, S.L.T.; writing—original draft preparation, S.L.T.; writing—review and editing, S.L.T., W.S.S.C., Y.B., G.B. and D.T.T.H.; visualization, Y.B. and S.L.T.; supervision, S.L.T. and D.T.T.H. All authors have read and agreed to the published version of the manuscript.
Funding
This research was funded by Abbott Nutrition Research and Development.
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Medical Research and Ethics Committee in Malaysia (protocol code NMRR-19-3929-52070 and date of approval 1 July 2020).
Informed Consent Statement
Informed consent was obtained from all participants involved in the study.
Data Availability Statement
The raw data supporting the conclusions of this article will be made available by the authors on request.
Conflicts of Interest
Siew Ling Tey, Geraldine Baggs, and Dieu Thi Thu Huynh are employees of Abbott. Yatin Berde was an employee of Cognizant Technologies Solution, a contract research organization that provides statistical services to Abbott Nutrition and has no competing interests. Winnie Siew Swee Chee reports receiving research grants and honoraria for consultancy from Abbott Nutrition and honoraria for consultancy or speaking engagements from Novo Nordisk, Merck, Boehringer Ingelheim, and AstraZeneca.
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).