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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01809925
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE March 13, 2013
Last Update Posted Date October 28, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
satiety (VAS Hunger 3-day average) [ Time Frame: Hours 0-4.5 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • Satiety Labeled Intensity Magnitude (SLIM) 3-day average [ Time Frame: Hours 0-4.5 ]
    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).
  • VAS Desire to Eat 3-day average [ Time Frame: Hours 0-4.5 ]
    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)
  • VAS Hunger 3-day average for hours 3.0 - 4.5 [ Time Frame: 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).
  • SLIM 3-day average for Hours 3.0-4.5 [ Time Frame: 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).
  • VAS Desire to Eat 3-day average for hours 3.0 - 4.5 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Hunger
Intervention  ICMJE
  • Dietary Supplement: psyllium fiber 6.8g
    Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
    Other Name: Metamucil Orange Sugar Free Fiber Singles (psyllium 6.8 g)
  • Dietary Supplement: placebo
    Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
Study Arms  ICMJE
  • Experimental: psyllium fiber 6.8g
    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.
    Intervention: Dietary Supplement: psyllium fiber 6.8g
  • Placebo Comparator: placebo
    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.
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2013)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809925
Other Study ID Numbers  ICMJE 2012126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Procter and Gamble
Study Sponsor  ICMJE Procter and Gamble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jose Brum, MD Procter and Gamble
PRS Account Procter and Gamble
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP