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HungerNCT01809925

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

A study testing psyllium fiber 6.8g in people with Hunger, run by Procter and Gamble at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Hunger
What is being tested?
psyllium fiber 6.8g
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
Mar 2013to Apr 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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);
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study Center

    Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: 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

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.

Read the 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
Being tested
psyllium fiber 6.8g, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psyllium fiber 6.8gDietary supplement

    Also called Metamucil Orange Sugar Free Fiber Singles (psyllium 6.8 g)

    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.

Study groups in NCT01809925
Study groupRoleWhat they receive
psyllium fiber 6.8gExperimentalTwo (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.
Receives: Dietary Supplement: psyllium fiber 6.8g
placeboPlacebo comparatorOne (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.
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Hours 0-4.5

Secondary outcomes (5)

  1. 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).

    Measured: Hours 0-4.5

  2. 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)

    Measured: Hours 0-4.5

  3. 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).

    Measured: Hours 3.0 - 4.5

  4. 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).

    Measured: Hours 3.0-4.5

  5. VAS Desire to Eat 3-day average for 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).

    Measured: Hours 3.0-4.5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809925
Sponsor's protocol ID
2012126
Status last verified
Mar 2013
First submitted
11 Mar 2013
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing psyllium fiber 6.8g in people with Hunger, run by Procter and Gamble at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

satiety (VAS Hunger 3-day average) (time frame: Hours 0-4.5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.

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