NCT01809925

Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers

Randomized, Double-blind, Placebo-controlled, 2-treatment, 3-period Crossover Design Study of the Efficacy and Tolerability of Psyllium 6.8 g Provided as Sugarfree Metamucil® Fiber Supplement Powder Versus Placebo on Satiety in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, 2-treatment, 3-period crossover design study to evaluate the effects of psyllium 6.8 g provided as sugarfree Metamucil fiber supplement powder dissolved in water versus placebo on satiety measures in healthy volunteers. This study will be conducted at a single study site.

Detailed description

A total of 45 subjects will be enrolled in this study. Approximately equal numbers of men and women will be enrolled, with a race distribution consistent with the US population. Eligible subjects will be randomly assigned to 1 of 2 test product sequences at Test Period 1 (Visit 2) using a block randomization. Subjects will participate in 3 test periods (Test Period 1, Visits 2-4; Test Period 2, Visits 5-7; and Test Period 3, Visits 8-10) and will receive test product once a day before breakfast for 3 days within each period. Test periods will be separated by a minimum 4-day washout period in which no test product will be administered.

Conditions

• Hunger

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	psyllium fiber 6.8g	Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
DIETARY_SUPPLEMENT	placebo	Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-03-13
• Last updated: 2014-10-28

Locations

1 site across 1 country: United States