Clinical trial NCT01809925: Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hunger
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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

Primary outcomes:
measure: satiety (VAS Hunger 3-day average)
timeFrame: Hours 0-4.5
Secondary outcomes:
measure: Satiety Labeled Intensity Magnitude (SLIM) 3-day average
timeFrame: Hours 0-4.5
measure: VAS Desire to Eat 3-day average
timeFrame: Hours 0-4.5
measure: VAS Hunger 3-day average for hours 3.0 - 4.5
timeFrame: Hours 3.0 - 4.5
measure: SLIM 3-day average for Hours 3.0-4.5
timeFrame: Hours 3.0-4.5
measure: VAS Desire to Eat 3-day average for hours 3.0 - 4.5
timeFrame: Hours 3.0-4.5
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Study Center
state: Ohio
Study officials:
affiliation: Procter and Gamble
name: Jose Brum, MD
role: STUDY_DIRECTOR
References: