Elsevier

Nutrition Research

Volume 30, Issue 12, December 2010, Pages 801-806
Nutrition Research

Dietary supplementation with d-tagatose in subjects with type 2 diabetes leads to weight loss and raises high-density lipoprotein cholesterol

https://doi.org/10.1016/j.nutres.2010.09.007Get rights and content

Abstract

Oral d-tagatose (d-tag) attenuates the rise in plasma glucose during an oral glucose tolerance test in subjects with type 2 diabetes mellitus (DM) and reduces food intake in healthy human subjects. A reduction in food consumption and less weight gain occur in rats fed tagatose. This pilot study explored the metabolic effects of d-tag given daily to 8 human subjects with type 2 DM for 1 year. We hypothesized that this treatment period would lead to weight loss and improvements in glycated hemoglobin and the lipid profile. A 2-month run-in period was followed by a 12-month treatment period when 15 g of oral d-tag was taken 3 times daily with food. No serious adverse effects were seen during the 12-month treatment period. Ten of the initially12 recruited subjects experienced gastrointestinal side effects that tended to be mild and transient. When 3 subjects were excluded who had oral diabetes, medications added and/or dosages increased during the study and mean (SD) body weight declined from 108.4 (9.0) to 103.3 (7.3) kg (P = .001). Glycated hemoglobin fell nonsignificantly from 10.6% ± 1.9% to 9.6% ± 2.3% (P = .08). High-density lipoprotein cholesterol progressively rose from a baseline level of 30.5 ± 15.8 to 41.7 ± 12.1 mg/dL at month 12 in the 6 subjects who did not have lipid-modifying medications added during the study (P < .001). Significant improvements in body weight and high-density lipoprotein cholesterol in this pilot study suggest that d-tag may be a potentially useful adjunct in the management of patients with type 2 DM.

Introduction

Nonnutritive sweeteners are used commonly to help patients with type 2 diabetes mellitus (DM) reduce carbohydrate energy intake to affect better glycemic control and to assist with weight management. d-Tagatose (d-tag) is a ketohexose bulk sweetener with no net metabolizable energy when fed to rats [1], [2]. d-tagatose received Generally Recognized as Safe status by the Food and Drug Administration in 2001 and entered the US market as a sweetener in 2003. In subjects with and without type 2 DM, a 75-g oral d-tag tolerance test led to no changes in plasma glucose or insulin levels. Pretreatment of type 2 DM subjects with doses of d-tag ranging from 10 to 75 g attenuated the rise in plasma glucose during an oral GTT in a dose-dependent manner [3]. These findings suggest that d-tag could potentially improve glycemic control in patients with type 2 DM by blunting postprandial hyperglycemia.

The long-term metabolic effects of d-tag have not previously been studied in humans. In a 90-day study in rats, d-tag given as 15% to 20% of daily energy intake led to less weight gain when compared with a control diet [4]. Reduced food intake has been observed in rats fed tagatose as 20% of daily energy intake [4] and in humans fed a single 29-g dose of tagatose when compared with 29 g of sucrose added to a breakfast meal [5]. If tagatose causes sustained reductions in energy intake, beneficial effects on weight, blood glucose control, and serum lipid profile could be seen. The objective of this pilot study was to investigate the metabolic effects of long-term administration of d-tag in obese subjects with type 2 DM. Following a 2-month run-in period, subjects had tagatose added to their daily meals and were followed on an every 2-month basis for 12 months for changes in weight, blood glucose control, and lipid profile. We hypothesized that daily oral tagatose would lower glycated hemoglobin (GlyHb) and lead to weight loss and improvements in the lipid profile, including lower low-density lipoprotein (LDL) cholesterol and triglycerides, and higher high-density lipoprotein (HDL) cholesterol.

Section snippets

Subjects

Eight subjects (4 male and 4 female) with type 2 DM for at least 1 year in duration were enrolled and ranged from 35 to 70 years in age. Four of the 12 initially screened subjects were excluded from analysis because they did not complete the study. Data analysis was performed on the 8 subjects who completed all 14 months of the study. Subjects were excluded from study entry if baseline GlyHb levels were lower than 8% (reference range, 4.4%-7.7%) or if they had gastrointestinal disorders. All

Results

Eight subjects completed the full 14 months of the study protocol and were included in the efficacy analyses. Of these 8 subjects, 4 were male and 4 female, with a mean age of 50.7 ± 10.9 years. At baseline, study subjects were obese, with a mean body mass index of 36.7 ± 5.1 kg/m2, and in poor glycemic control, with a mean GlyHb of 11.2% ± 2.0%. Subjects were also dyslipidemic at baseline, with a mean total cholesterol of 224 ± 28 mg/dL; LDL cholesterol, 146 ± 3) mg/dL; triglycerides, 226 ± 98

Discussion

This pilot study is the first to investigate the long-term metabolic effects of d-tag in humans with type 2 DM. No adverse metabolic or biochemical effects were noted among the 8 subjects who completed the study. Indeed, significant and beneficial changes were seen in weight and HDL cholesterol at the end of the 12-month intervention period, in the absence of any intentional changes in dietary intake or physical activity. No significant changes in GlyHb or other lipid parameters were seen.

The

Acknowledgment

We would like to thank Maryland Industrial Partnerships, Glenn L. Martin Institute of Technology, University of Maryland, College Park, and Spherix Incorporated (Beltsville, Md) for their financial support of this study. We are most grateful to Debra Ostrowski for her expert technical assistance and to Alan Shuldiner for his critical review of the manuscript.

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    Financial support was received from Maryland Industrial Partnerships, Glenn L. Martin Institute of Technology, University of Maryland, College Park, and Spherix Inc, Beltsville, Md.

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