Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| General Mills | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objective of this study is to assess self-reported gastrointestinal (GI) responses to three snack bars containing fiber/fiber blends vs. a control snack bar for 7 days each in adults using GLP-1 agonists.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental - Inulin | Experimental |
| |
| Experimental - Fiber Blend | Experimental |
| |
| Experimental - Resistant Starch Type 4 | Experimental |
| |
| Control - Low Fiber | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Fiber Bar with Inulin | Other | Bar with Inulin - high fiber |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite GI Symptom Score | Composite GI Symptom Score is from the GI Tolerability Questionnaire. The composite score will be calculated as the sum of the individual components (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence). The ratings will be coded as: 1 = none/much less than usual, 2 = less than usual, 3 = about usual, 4 = more than usual, and 5 = much more than usual. There will be one composite score per day. Baseline will be defined as the average of the composite scores for the 3-day baseline period. The value for each intervention will be defined as the average of the composite scores for the 7-day intervention period. | Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the ratings for the individual component scores of the GIL Tolerability Questionnaire (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence). | For each individual component, the ratings for the 3-day baseline period and the 7-day intervention period will be summed and divided by 3 and 7, respectively, before the change from baseline is calculated. | Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, PhD | MB Clinical Research and Consulting LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excellence Medical and Research | Miami Gardens | Florida | 33169 | United States | ||
| Health Awareness |
Not provided
Not provided
Not provided
Not provided
Not provided
| High Fiber bar with Fiber Blend |
| Other |
Bar with a fiber blend of psyllium husk and bran fibers - high fiber |
|
| High Fiber Bar with Resistant Starch type 4 | Other | Bar with Resistant Starch type 4 - High Fiber |
|
| Low Fiber Bar | Other | Snack Bar - Low Fiber |
|
| The frequency of the individual component scores of the GI Tolerability Questionnaire (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence) of 4 or higher (more than usual or much more than usual) during the 7-day intervention period. | Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period. |
| Change from baseline in the Bristol Stool Form Scale (BSFS) | The scores for the 3-day baseline period and the 7-day intervention period will be summed and divided by the number of bowel movements that occurred during the respective period before the change from baseline is calculated. | Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period. |
| Change from baseline in the ratings of stool hardness, straining, discomfort, and incomplete evacuation. | The raitings for the 3-day baseline period and the 7-day intervention period will be summed and divided by the number of bowel movements that occurred during the respective period before the change from baseline is calculated. | Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period. |
| Port Saint Lucie |
| Florida |
| 34952 |
| United States |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
Not provided
Not provided