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Fiber Supplement
psyllium fiber 6.8g for Hunger
N/A
Waitlist Available
Research Sponsored by Procter and Gamble
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hours 3.0-4.5
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hours 3.0-4.5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hours 3.0-4.5
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
satiety (VAS Hunger 3-day average)
Secondary study objectives
SLIM 3-day average for Hours 3.0-4.5
Satiety Labeled Intensity Magnitude (SLIM) 3-day average
VAS Desire to Eat 3-day average
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: psyllium fiber 6.8gExperimental Treatment1 Intervention
Two (2) packets Metamucil Orange Sugar Free Fiber Singles (psyllium 6.8 g) thoroughly mixed in Ten (10) ounces of water. Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
Group II: placeboPlacebo Group1 Intervention
One (1) level teaspoon of placebo product thoroughly mixed in Ten (10) ounces of water. Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
psyllium fiber 6.8g
2013
N/A
~50
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Who is running the clinical trial?
Procter and GambleLead Sponsor
147 Previous Clinical Trials
76,653 Total Patients Enrolled
Jose Brum, MDStudy DirectorProcter and Gamble
4 Previous Clinical Trials
680 Total Patients Enrolled
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