An interventional study of Inulin in Healthy, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
The purpose of this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10-gram dose of inulin among healthy adult volunteers.
The Study involves 2 visits and will include 3 types of subjects. Any healthy adult between the ages of 18 and 75 with no prior history of GI disease or symptoms is eligible to participate in the study.
Visit 1 (Day 1) - Screening Visit and Informed Consent At this Visit volunteers will do the following
Day 2 (at home):
Day 3 to 4 (at home) - The second 24-hour stool collection will begin starting at 7 am on Day 3 and continue until 7 am Day 4. Volunteers will record the diet for Day 3 to 4 as "Day 3 Diet" and will record bowel symptoms using a Bowel Diary Card.
Day 4 to 5 (at home)- Volunteers will start third 24-hour stool collection at 7 am on Day 4 and continue until 7 am Day 5. The diet for Day 4 to 5 should be recorded as "Day 4 Diet." Volunteers will record the bowel symptoms using a Bowel Diary Card.
Day 5 to 6 (at home)- The fourth 24-hour stool collection begins at 7 am on Day 5 and continue until 7 am Day 6. Volunteers will record the diet for Day 5 to 6 as "Day 5 Diet" and will record bowel symptoms using a Bowel Diary Card.
Visit 2 (Day 6) - End of study: Volunteers will return the refrigerated stool specimens, bowel diaries and dietary intake diaries to the study team. Diaries may also be returned by mail, fax, or by electronic submission. For the diet diaries, volunteers will have the option to complete paper diaries or the Automated Self-Administered Dietary Assessment. Volunteers' participation in the study will end after this visit.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms.
Dietary Supplement: Inulin
Inulin ingestion is not being used to diagnose, treat, or prevent irritable bowel syndrome. Inulin is being used to study an individual's ability to ferment dietary fiber.
Fecal Inulin
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
Time frame: 4 days
Total Fecal Short Chain Fatty Acids
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Time frame: 4 days
Individual Fecal Short Chain Fatty Acids
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Time frame: 4 days
Bowel Frequency
Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Bowel frequency indicates the total number of bowel movements in 4 days.
Time frame: 4 days
Dietary Intake
Baseline dietary intake will be measured using an automated self-administered dietary assessment tool
Time frame: 24 hours
Bowel Symptoms
Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage, 3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy, 7=watery, summarized on the level of bowel movements. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.
Time frame: 4 days
| Milestone | Healthy Volunteers |
|---|---|
| Started | 29 |
| Completed | 22 |
| Not completed | 7 |
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
| ug/1 mL extract | Healthy Volunteers |
|---|---|
| Fecal Inulin | 45.2 (34.6 to 58.6) |
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
| mmol/kg | Healthy Volunteers |
|---|---|
| Total Fecal Short Chain Fatty Acids | 207.4 (159.7 to 375.5) |
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
| mmol/kg | Healthy Volunteers |
|---|---|
| Acetic Acid | 111.5 (99.4 to 279.7) |
| Priopionic Acid | 37.3 (26.8 to 63.5) |
| Butyric Acid | 51 (25.1 to 60.3) |
Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Bowel frequency indicates the total number of bowel movements in 4 days.
| Number of bowel movements | Healthy Volunteers |
|---|---|
| Bowel Frequency | 4 (4 to 4) |
Baseline dietary intake will be measured using an automated self-administered dietary assessment tool
| kcal | Healthy Volunteers |
|---|---|
| Dietary Intake | 2065.9 (1415.6 to 2666.1) |
Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage, 3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy, 7=watery, summarized on the level of bowel movements. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.
| units on a scale | Healthy Volunteers |
|---|---|
| Stool form | 4 (3 to 5) |
| Ease of passage | 4 (4 to 4) |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Volunteers | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Healthy Volunteers |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 1 |
| Age, Continuous(years) | Healthy Volunteers |
|---|---|
| Mean | 39.6 ± 15.5 |
| Sex: Female, Male(Participants) | Healthy Volunteers |
|---|---|
| Female | 13 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Volunteers |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 26 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Healthy Volunteers |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
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