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

NCT ID: NCT01809925

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-04-30

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.

Conditions

Hunger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

psyllium fiber 6.8g

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

psyllium fiber 6.8g

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

Intervention Type: DIETARY_SUPPLEMENT

placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Metamucil Orange Sugar Free Fiber Singles (psyllium 6.8 g)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Brum, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Study Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2012126

Identifier Type: -

Identifier Source: org_study_id