Trial Outcomes & Findings for Healthy Volunteer Short Chain Fatty Acid Study (NCT NCT05254340)

NCT ID: NCT05254340

Last Updated: 2024-09-25

Results Overview

Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2024-09-25

Participant Flow

Participant milestones

Measure	Healthy Volunteers Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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. All subjects received the same intervention so we report them as one group with no stratification.
Overall Study STARTED	29
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex was not reported for 3 subjects

Baseline characteristics by cohort

Measure	Healthy Volunteers n=29 Participants Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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.
Age, Categorical <=18 years	0 Participants n=29 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=29 Participants
Age, Categorical >=65 years	1 Participants n=29 Participants
Age, Continuous	39.6 years STANDARD_DEVIATION 15.5 • n=29 Participants
Sex: Female, Male Female	13 Participants n=26 Participants • Sex was not reported for 3 subjects
Sex: Female, Male Male	13 Participants n=26 Participants • Sex was not reported for 3 subjects
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=29 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=29 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=29 Participants
Race (NIH/OMB) Asian	9 Participants n=29 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants
Race (NIH/OMB) Black or African American	4 Participants n=29 Participants
Race (NIH/OMB) White	13 Participants n=29 Participants
Race (NIH/OMB) More than one race	0 Participants n=29 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=29 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Fecal inulin was missing for 7 subjects who completed the study

Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography

Outcome measures

Measure	Healthy Volunteers n=15 Participants Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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	45.2 ug/1 mL extract Interval 34.6 to 58.6

PRIMARY outcome

Timeframe: 4 days

Population: One subject completing the study had missing data on 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

Outcome measures

Measure	Healthy Volunteers n=21 Participants Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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.
Total Fecal Short Chain Fatty Acids	207.4 mmol/kg Interval 159.7 to 375.5

PRIMARY outcome

Timeframe: 4 days

Population: One subject completing the study had missing data on 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

Outcome measures

Measure	Healthy Volunteers n=21 Participants Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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.
Individual Fecal Short Chain Fatty Acids Acetic Acid	111.5 mmol/kg Interval 99.4 to 279.7
Individual Fecal Short Chain Fatty Acids Priopionic Acid	37.3 mmol/kg Interval 26.8 to 63.5
Individual Fecal Short Chain Fatty Acids Butyric Acid	51 mmol/kg Interval 25.1 to 60.3

SECONDARY outcome

Timeframe: 4 days

Population: 5 subjects did not complete the bowel diary, resulting in missing data.

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.

Outcome measures

Measure	Healthy Volunteers n=17 Participants Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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.
Bowel Frequency	4 Number of bowel movements Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: 24 hours

Baseline dietary intake will be measured using an automated self-administered dietary assessment tool

Outcome measures

Measure	Healthy Volunteers n=18 Participants Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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.
Dietary Intake	2065.9 kcal Interval 1415.6 to 2666.1

SECONDARY outcome

Timeframe: 4 days

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.

Outcome measures

Measure	Healthy Volunteers n=65 Bowel movements Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. 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.
Bowel Symptoms Stool form	4 units on a scale Interval 3.0 to 5.0
Bowel Symptoms Ease of passage	4 units on a scale Interval 4.0 to 4.0

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Huiping Xu

Indiana University

Phone: 317-278-6735

Email: huipxu@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place