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

NCT01809925 | Completed

• 1 other identifier: 2012126
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hunger

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Satiety Labeled Intensity Magnitude (SLIM) 3-day average

  Hours 0-4.5

• VAS Desire to Eat 3-day average

  Hours 0-4.5

• VAS Hunger 3-day average for hours 3.0 - 4.5

  Hours 3.0 - 4.5

• SLIM 3-day average for Hours 3.0-4.5

  Hours 3.0-4.5

• VAS Desire to Eat 3-day average for hours 3.0 - 4.5

  Hours 3.0-4.5

Study Arms (2)

psyllium fiber 6.8g

EXPERIMENTAL

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.

Dietary Supplement: psyllium fiber 6.8g

placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: placebo

Interventions

psyllium fiber 6.8g DIETARY_SUPPLEMENT

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

Also known as: Metamucil Orange Sugar Free Fiber Singles (psyllium 6.8 g)

psyllium fiber 6.8g

placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Study Center

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Interventions

Psyllium

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Jose Brum, MD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2013-03

Locations

US (1)