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Nutrients 2018, 10(8), 1022;

Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients

West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Hohensandweg 37, 40591 Düsseldorf, Germany
Faculty of Medicine, Heinrich Heine University Düsseldorf, 40225 Düsseldorf, Germany
Author to whom correspondence should be addressed.
Equal authorship.
Received: 14 June 2018 / Revised: 28 July 2018 / Accepted: 1 August 2018 / Published: 4 August 2018
(This article belongs to the Special Issue Personalized Nutrition)
PDF [2275 KB, uploaded 4 August 2018]


Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care. View Full-Text
Keywords: type 2 diabetes; low-carbohydrate diet; HbA1c; weight loss; formula diet type 2 diabetes; low-carbohydrate diet; HbA1c; weight loss; formula diet

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Kempf, K.; Röhling, M.; Niedermeier, K.; Gärtner, B.; Martin, S. Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients. Nutrients 2018, 10, 1022.

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