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Open Access Research

Effect of two dietary fibers on satiety and glycemic parameters: a randomized, double-blind, placebo-controlled, exploratory study

David M Savastano1, Rebecca J Hodge2*, Derek J Nunez2, Ann Walker3 and Roxanne Kapikian4

Author Affiliations

1 Medical Affairs, Consumer Healthcare, GlaxoSmithKline, Parsippany, NJ, USA

2 Discovery Medicine, GlaxoSmithKline, Five Moore Drive, MS N2-3208, Research Triangle Park, NC 27709, USA

3 Statistics and Programming, GlaxoSmithKline, Research Triangle Park, NC, USA

4 Biostatistics, Consumer Healthcare, GlaxoSmithKline, Parsippany, NJ, USA

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Nutrition Journal 2014, 13:45  doi:10.1186/1475-2891-13-45

Published: 17 May 2014

Abstract

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

Keywords:
OFS; Pectin; Dietary fibers; Glucose; Satiety