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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psyllium fiber 6.8g | Dietary Supplement | Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Subjects who meet all of the following criteria are eligible to participate in the study:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Brum, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Center | Cincinnati | Ohio | 45227 | United States |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| placebo | Dietary Supplement | Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit. |
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| 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) | 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). | 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). | Hours 3.0-4.5 |
| 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). | Hours 3.0-4.5 |