Status:
COMPLETED
Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers
Lead Sponsor:
Procter and Gamble
Conditions:
Hunger
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 d...
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...
Eligibility Criteria
Inclusion
- Subjects who meet all of the following criteria are eligible to participate in the study:
- routinely eat breakfast daily;
- agree to eat 100% of the food provided during the study, drink 10 ounces of water with the test product immediately before breakfast, and only eat a light snack after dinner before fasting overnight beginning at 10:00 PM prior to the next visit;
- have a screening VAS Hunger score \> 50 before eating breakfast that moves towards less hunger after eating breakfast;
- have 1-2 bowel movements per day that are typically rated as 3, 4, or 5 on the Bristol Stool Form Scale;
- in good general health based on medical history;
- if female, be postmenopausal or if of child-bearing capacity agree to use an adequate form of contraception (eg, surgical sterilization, birth control pills, birth control implants, condoms AND spermicide, abstinence);
- have a body mass index (BMI) ≥ 18.5 but \< 28 kg/m2;
- able to fulfill the requirements of the protocol and provide written consent;
- willing to abstain from any weight control or satiety supplements during the study;
- willing to refrain from taking any psyllium containing products or fiber supplements during the study with the exception of the test products;
- willing to maintain lifestyle habits for the duration of the study (eg, do not change exercise habits or begin a weight loss diet);
- willing to refrain from exercise on the mornings prior to arriving at the study site;
- willing to abstain from alcohol for 2 days prior to the first day of each test period through the last day of each test period;
- willing not to consume caffeine for 24 hours prior to the first day of each test period through the last day of each test period.
Exclusion
- Subjects will be excluded from the study if they meet any of the following criteria:
- have any history of heart, liver, kidney, nerve, blood disorder, or cancer(except for treated basal cell cancer with a documented 6-month remission), or metabolic, hormone, or gastrointestinal (GI) disease;
- have a history of an eating disorder;
- have difficulty swallowing;
- have a history of gastrointestinal surgery (except appendectomy) or gastrointestinal bleeding;
- are currently alcohol or chemically dependent (a urine test for drugs of abuse will be given);
- report use of tobacco, smoking cessation products, or products containing nicotine within 3 months;
- have a significant psychiatric disorder;
- any use of prescription drugs, with the exception of birth control pills, within 14 days prior to the study or antibiotics in the past 30 days;
- any use of non-prescription drugs within 7 days prior to the study;
- used psyllium containing products or fiber supplements within the past month;
- have a history of phenylketonuria (PKU);
- have a history of a severe allergic reaction to psyllium;
- are currently on a structured formal diet (eg, Jenny Craig, Atkins);
- typically drink more than 70 ounces of liquid during the day (ie, approximately 4 bottles of water, each 16.9 ounces)
- have a history or presence, upon clinical evaluation, of any illness or condition that might impact the safety of the study product;
- participated in a clinical drug study or used an investigational new drug within 30 days of dosing;
- pregnant or nursing, if female;
- engage in excessive exercise that is extreme in frequency or duration;
- find the study meals unpalatable
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01809925
Start Date
March 1 2013
End Date
April 1 2013
Last Update
October 28 2014
Active Locations (1)
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1
Study Center
Cincinnati, Ohio, United States, 45227