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

Procter and Gamble45 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Hunger

Interventions

psyllium fiber 6.8gDIETARY_SUPPLEMENT

Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.

placeboDIETARY_SUPPLEMENT

Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Study Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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).

Time frame: Hours 0-4.5

Secondary Outcomes

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).

Time frame: Hours 0-4.5

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)

Time frame: Hours 0-4.5

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).

Time frame: Hours 3.0 - 4.5

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).

Data from ClinicalTrials.gov

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