Hunger Clinical Trial
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
Verified date | March 2013 |
Source | Procter and Gamble |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Study Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | satiety (VAS Hunger 3-day average) | VAS Hunger 3-day average. This endpoint will be calculated by averaging all evaluable post-breakfast scores across Days 1, 2, and 3. VAS Hunger is assessed on a horizontal 100-mm VAS anchored on the left by the phrase "Not at all hungry" (score = 0) and on the right by "As hungry as I have ever felt" (score = 100). | Hours 0-4.5 | No |
Secondary | Satiety Labeled Intensity Magnitude (SLIM) 3-day average | SLIM 3-day average is calculated by averaging all evaluable post-breakfast scores across Days 1, 2, and 3. SLIM scale gauges perceived hunger/fullness following a meal using 11 phrases placed along a vertical line scale anchored at the bottom by "Greatest imaginable hunger" (score = -100) and at the top by "Greatest imaginable fullness" (score = 100). | Hours 0-4.5 | No |
Secondary | VAS Desire to Eat 3-day average | The VAS Desire to Eat 3-day average is calculated by averaging all evaluable post-breakfast scores across Days 1, 2, and 3. The VAS Desire to Eat Scale asks subjects to rate their desire to eat using a horizontal 100-mm VAS anchored on the left by the phrase "No desire at all" (score = 0) and on the right by "As strong as I have ever felt" (score = 100) | Hours 0-4.5 | No |
Secondary | VAS Hunger 3-day average for hours 3.0 - 4.5 | The VAS Hunger 3-day average for hours 3.0 - 4.5 is calculated by averaging all evaluable post-breakfast scores for hours 3.0, 3.5, 4.0, and 4.5 across Days 1, 2, and 3. The VAS Desire to Eat Scale asks subjects to rate their desire to eat using a horizontal 100-mm VAS anchored on the left by the phrase "No desire at all" (score = 0) and on the right by "As strong as I have ever felt" (score = 100). | Hours 3.0 - 4.5 | No |
Secondary | SLIM 3-day average for Hours 3.0-4.5 | SLIM 3-day average for Hours 3.0-4.5 is calculated by averaging all evaluable post-breakfast scores for hours 3.0, 3.5, 4.0, and 4.5 across Days 1, 2, and 3. The SLIM scale gauges perceived hunger/fullness following a meal using 11 phrases placed along a vertical line scale anchored at the bottom by "Greatest imaginable hunger" (score = -100) and at the top by "Greatest imaginable fullness" (score = 100). | Hours 3.0-4.5 | No |
Secondary | VAS Desire to Eat 3-day average for hours 3.0 - 4.5 | The VAS Desire to Eat 3-day average for hours 3.0-4.5 is calculated by averaging all evaluable post-breakfast scores for hours 3.0, 3.5, 4.0, and 4.5 across Days 1, 2, and 3. The VAS Desire to Eat Scale asks subjects to rate their desire to eat using a horizontal 100-mm VAS anchored on the left by the phrase "No desire at all" (score = 0) and on the right by "As strong as I have ever felt" (score = 100). | Hours 3.0-4.5 | No |
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