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Published on: July 31, 2019
Effect of two dietary fibers on satiety and glycemic parameters: a randomized, double-blind, placebo-controlled,
David M Savastano, Rebecca J Hodge1, Derek J Nunez
1Discovery Medicine, GlaxoSmithKline, Five Moore Drive, MS N2-3208, Research Triangle Park, NC 27709, USA. rebecca.j.hodge@gsk.com.
Background:
Dietary carbohydrates may affect metabolic and physiologic parameters. The present study evaluated whether a combination of two dietary fibers, oligofructose (OFS) and pectin (P), altered satiety and glycemic parameters. The primary objective of this study was to determine whether dietary supplementation for 3 weeks with OFS + P would produce a greater reduction in energy intake of an ad libitum test meal compared to control.
Methods:
This was a single center, randomized, double-blind, placebo-controlled, parallel group study in overweight and obese, otherwise healthy, subjects (N = 96). There were two OFS + P treatment groups: high-dose (30 g/d), low-dose (15 g/d), and a control group (maltodextrin 15 g/d). Energy intake, appetite measures based on Satiety Labeled Intensity Magnitude (SLIM) scale, fasting and post-prandial glucose, and insulin levels and body weight were measured at baseline and at the end of 3 weeks. Adverse events and gastrointestinal tolerability of the treatments were also assessed.
Results:
An analysis of covariance (ANCOVA) performed on the primary endpoint change from baseline in energy intake, showed no statistically significant difference in energy intake among the three treatment groups (p = 0.5387). The LS mean changes (SE) in energy intake from baseline to week 3 were -58.3 (42.4) kilocalories (kcal) for the high dose group, -74.2 (43.6) kcal for the low dose group, and -9.0 (42.9) kcal for the control group. For the pairwise comparisons of OFS + P doses and control, confidence intervals were constructed around the difference in LS mean changes. All study products were generally well tolerated.
Conclusion:
There was a directional benefit in ad libitum energy intake for both OFS + P doses compared to control, with a greater reduction in kilocalories in the low dose comparison, but the reductions were not significant. Further studies are warranted.
Clinical Trial Registration:
GSK Clinical Study Register # W7781293.
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