NCT04515277

Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake

Double-blind, Randomized, Controlled, Three-way Cross-over Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose and Insulin Levels and Food Intake

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Nexira · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be assessed.

Detailed description

Gum arabic is a heteropolysaccharide (molecular weight 350-850 kDa) harvested from Acacia seyal or Acacia senegal. It is highly soluble and broadly used in numerous solid and liquid food matrices. For the assessment of non-digestible carbohydrates as dietary fiber, it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study. The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels, post-prandial insulin levels and prospective ad libitum food intake, in normal-weight and overweight subjects. The present double-blind, randomized, controlled, three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose (PPG) levels in normal-weight and overweight subjects during a 2-7 weeks intervention period. Additionally, post-prandial insulin (PPI) levels, prospective ad libitum food intake, as well as the safety and tolerability of gum acacia were assessed.

Conditions

• Healthy
• Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	40 g Gum acacia (FibregumTM)	Applied in 300 mL of orange juice with breakfast (single use at visit)
DIETARY_SUPPLEMENT	20 g Gum acacia (FibregumTM)	Applied in 300 mL of orange juice with breakfast (single use at visit)
DIETARY_SUPPLEMENT	0 g Gum acacia (FibregumTM)	300 mL of orange juice with breakfast (single use at visit)

Timeline

• Start date: 2019-06-28
• Primary completion: 2019-09-27
• Completion: 2019-09-27
• First posted: 2020-08-17
• Last updated: 2020-08-19

Locations

1 site across 1 country: Germany