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

Completed · Not applicable · Has a placebo group

Conditions studied: Hunger

In brief

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.

Key facts

Study ID

NCT01809925

Run by

Procter and Gamble

People needed

45

Starts

2013-03-01

Expected to finish

2013-04-01

Last updated by the study team

2014-10-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.