Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628869
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
The Effects of Oral Fructanase Administration on Gastrointestinal Symptoms After Inulin Challenge in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Oral Fructanase Administration on Gastrointestinal Symptoms After Inulin Challenge in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The carbohydrate inulin from chicory root is a healthy prebiotic ingredient found in dietary supplements and fortified foods Nagy et al Inulin is representative of a broader class of typically health-associated yet fermentable carbohydrates called fructans that occur naturally in many vegetables fruits and wheat Fructans or long chains of fructose units are resistant to human digestive enzyme hydrolysis and transit intact to the small intestine and colon where they undergo rapid fermentation by intestinal microbes This microbial metabolism of fructans produces gas and other fermentation byproducts that can lead to excess gastrointestinal GI symptoms like abdominal bloating cramping stomach rumbling and flatulence Bonnema et al Briet et al Bruhwyler et al especially in individuals with irritable bowel syndrome Van den Houte et al A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption Positive findings from in vitro digestion simulations Guice et al and a first-in-human safety trial Garvey et al helped define the fructanase dose for this clinical trial-the primary objective of which is to investigate the effect of oral fructanase administration on GI symptoms in healthy adults after consuming oatmeal with added inulin 25 grams Secondary outcomes include breath hydrogen and methane levels which serve as biomarkers of intestinal microbial fermentation The investigators hypothesize that fructanase administration will lower the severity of GI symptoms after inulin consumption as well as lower breath biomarkers of intestinal microbial fermentation compared to placebo
Detailed Description:
Fructanase also known as inulinase fructan hydrolase beta-fructosidase and beta-fructofuranosidase represents an innovative enzymatic approach to hydrolyze dietary fructans and improve fructan-type fermentable oligo- di- monosaccharides and polyols FODMAP tolerance We have previously shown in vitro that a microbial fructanase obtained by fermentation of Aspergillus tubingensis effectively hydrolyzes a variety of dietary inulins and fructans following simulated oro-gastric digestion in the static INFOGEST model Guice et al We have also completed a Phase I clinical trial in healthy adults demonstrating the safety and tolerability of twice daily fructanase supplementation total 2000 inulinase activity units INU per day for 4 weeks Garvey et al Despite its safety and promising application in nutrition and GI health rigorous clinical evaluation of fructanases efficacy in improving GI tolerance to fructans is warranted
This is a randomized double-blind two-period crossover study with one screening visit Visit 1 Day -7 and two test visits Visits 2 and 3 Days 0 and 7 Participants will arrive for their screening visit on Day -7 After participants provide voluntary informed consent participants will undergo medical history prior and current medicationsupplement use inclusion and exclusion criteria assessments and last menses query if applicable Additionally height body weight and vital signs will be measured and theoretical body mass index BMI will be calculated An in-clinic urine pregnancy test will be performed on all female participants Participants will be instructed to maintain physical activity and habitual diet as much as possible while abstaining from supplements beverages or food products with digestive enzymes prebiotic ingredients live probiotics eg yogurt kombucha or postbiotic ingredients prior to Visit 2 Day 0 Those who are taking exclusionary supplements foods and beverages will be instructed to stop taking these products and their Visit 2 Day 0 will be scheduled to allow for the appropriate pre-randomization washout period Additionally pre-menopausal female participants will be scheduled to allow their Visit 2 Day 0 to occur during the menstrual cycle follicular phase defined as days 1-14 of the menstrual cycle with day 1 as the first day of menses To all participants a standardized low FODMAP meal will be dispensed with instructions to consume the meal in its entirety the evening prior to Visit 2 Day 0 The instructions will include timing of meal consumption in order to maintain the appropriate fast Participants will also be instructed to follow a low FODMAP diet the day prior to Visit 2 while also being reminded to abstain from alcohol consumption for 48 h to abstain from vigorous exercise for 24 h to fast 10 h water only and to brush their teeth in the morning prior to Visit 2 Day 0
At Visit 2 Day 0 participants will arrive at the clinic in a fasting state 10 h water only Eligible participants will undergo clinic visit procedures concomitant medicationsupplement use assess inclusionexclusion criteria and body weight last menses query where applicable and adverse event AE assessment Participants will be queried about compliance with study instructions and changes to habitual lifestyle diet and alcohol consumption At t -025 h 5 min where t 0 h is the time of study product consumption participants will provide a breath sample for hydrogen and methane analysis and complete a questionnaire to assess baseline GI symptoms prior to study product consumption Participants will then be randomized to a study product sequence and will be administered their assigned study product capsule fructanase or placebo that will be consumed with oatmeal and 25 g of inulin t 0 h In addition 8 oz of water will be provided Participants will be allowed up to 10 minutes to completely consume the oatmeal and inulin mixture with fructanase or placebo with t 0 h designated as the start of study product consumption Following study product consumption participants will complete the GI symptom questionnaire and provide a breath sample for hydrogen and methane analysis at t 1 2 3 4 5 6 7 and 8 h 5 min Participants will also be provided with 8 oz of water at t 2 and 4 h Participants will be allowed to drink each 8 oz of water ad libitum over each 2 h period but the entire 8 oz of water must be consumed prior to the next water administration eg drink all 8 oz provided at t 2 h prior to the next water administration at t 4 h A standard low FODMAP lunch with 8 oz of water will be provided after the t 6 h assessments
Prior to departure from the study center AEs will be assessed then study instructions will be provided including 1 maintaining habitual physical activity 2 continuing to follow the low FODMAP diet for the remainder of the day 3 abstaining from alcohol consumption for the remainder of the day and 4 abstaining from supplements beverages or food products with digestive enzymes prebiotic ingredients live probiotics eg yogurt kombucha or postbiotic ingredients throughout the study The same standardized low FODMAP meal consumed the evening prior to Visit 2 will be dispensed with instructions to consume the meal in its entirety the evening prior to Visit 3 Day 7 The instructions will include timing of meal consumption in order to maintain the appropriate fast Participants will also be instructed to follow a low FODMAP diet the day prior to Visit 3 Day 7 while also being reminded to abstain from alcohol consumption for 48 h to abstain from vigorous exercise for 24 h to fast 10 h water only and to brush their teeth in the morning prior to Visit 3 Day 7
The following morning Day 1 participants will receive an email link at t 24 h to complete a series of brief questionnaires including
Modified Single-Item Sleep Quality Scale
Single-Item Stool Consistency Scale
GI-VAS assessing symptoms since participant left the clinic
A single question to confirm compliance with study instructions
Participants will be instructed to complete these questionnaires the morning of Day 1 after their first bowel movement or immediately prior to their usual lunch time whichever occurs first
At Visit 3 Day 7 participants will arrive at the clinic fasted 10 h water only and undergo clinic visit procedures including concomitant medicationsupplement use review inclusionexclusion criteria and body weight last menses query if applicable and AE assessment Participants will be queried about compliance with study instructions and changes to habitual lifestyle diet and alcohol consumption Participants will then complete all study procedures outlined in Visit 2 except for randomization The same timing and volume of water consumed at Visit 2 will be replicated at Visit 3 The same lunch items and quantity consumed at Visit 2 will be replicated at Visit 3
This is a randomized double-blind two-period crossover study with one screening visit Visit 1 Day -7 and two test visits Visits 2 and 3 Days 0 and 7 Participants will arrive for their screening visit on Day -7 After participants provide voluntary informed consent participants will undergo medical history prior and current medicationsupplement use inclusion and exclusion criteria assessments and last menses query if applicable Additionally height body weight and vital signs will be measured and theoretical body mass index BMI will be calculated An in-clinic urine pregnancy test will be performed on all female participants Participants will be instructed to maintain physical activity and habitual diet as much as possible while abstaining from supplements beverages or food products with digestive enzymes prebiotic ingredients live probiotics eg yogurt kombucha or postbiotic ingredients prior to Visit 2 Day 0 Those who are taking exclusionary supplements foods and beverages will be instructed to stop taking these products and their Visit 2 Day 0 will be scheduled to allow for the appropriate pre-randomization washout period Additionally pre-menopausal female participants will be scheduled to allow their Visit 2 Day 0 to occur during the menstrual cycle follicular phase defined as days 1-14 of the menstrual cycle with day 1 as the first day of menses To all participants a standardized low FODMAP meal will be dispensed with instructions to consume the meal in its entirety the evening prior to Visit 2 Day 0 The instructions will include timing of meal consumption in order to maintain the appropriate fast Participants will also be instructed to follow a low FODMAP diet the day prior to Visit 2 while also being reminded to abstain from alcohol consumption for 48 h to abstain from vigorous exercise for 24 h to fast 10 h water only and to brush their teeth in the morning prior to Visit 2 Day 0
At Visit 2 Day 0 participants will arrive at the clinic in a fasting state 10 h water only Eligible participants will undergo clinic visit procedures concomitant medicationsupplement use assess inclusionexclusion criteria and body weight last menses query where applicable and adverse event AE assessment Participants will be queried about compliance with study instructions and changes to habitual lifestyle diet and alcohol consumption At t -025 h 5 min where t 0 h is the time of study product consumption participants will provide a breath sample for hydrogen and methane analysis and complete a questionnaire to assess baseline GI symptoms prior to study product consumption Participants will then be randomized to a study product sequence and will be administered their assigned study product capsule fructanase or placebo that will be consumed with oatmeal and 25 g of inulin t 0 h In addition 8 oz of water will be provided Participants will be allowed up to 10 minutes to completely consume the oatmeal and inulin mixture with fructanase or placebo with t 0 h designated as the start of study product consumption Following study product consumption participants will complete the GI symptom questionnaire and provide a breath sample for hydrogen and methane analysis at t 1 2 3 4 5 6 7 and 8 h 5 min Participants will also be provided with 8 oz of water at t 2 and 4 h Participants will be allowed to drink each 8 oz of water ad libitum over each 2 h period but the entire 8 oz of water must be consumed prior to the next water administration eg drink all 8 oz provided at t 2 h prior to the next water administration at t 4 h A standard low FODMAP lunch with 8 oz of water will be provided after the t 6 h assessments
Prior to departure from the study center AEs will be assessed then study instructions will be provided including 1 maintaining habitual physical activity 2 continuing to follow the low FODMAP diet for the remainder of the day 3 abstaining from alcohol consumption for the remainder of the day and 4 abstaining from supplements beverages or food products with digestive enzymes prebiotic ingredients live probiotics eg yogurt kombucha or postbiotic ingredients throughout the study The same standardized low FODMAP meal consumed the evening prior to Visit 2 will be dispensed with instructions to consume the meal in its entirety the evening prior to Visit 3 Day 7 The instructions will include timing of meal consumption in order to maintain the appropriate fast Participants will also be instructed to follow a low FODMAP diet the day prior to Visit 3 Day 7 while also being reminded to abstain from alcohol consumption for 48 h to abstain from vigorous exercise for 24 h to fast 10 h water only and to brush their teeth in the morning prior to Visit 3 Day 7
The following morning Day 1 participants will receive an email link at t 24 h to complete a series of brief questionnaires including
Modified Single-Item Sleep Quality Scale
Single-Item Stool Consistency Scale
GI-VAS assessing symptoms since participant left the clinic
A single question to confirm compliance with study instructions
Participants will be instructed to complete these questionnaires the morning of Day 1 after their first bowel movement or immediately prior to their usual lunch time whichever occurs first
At Visit 3 Day 7 participants will arrive at the clinic fasted 10 h water only and undergo clinic visit procedures including concomitant medicationsupplement use review inclusionexclusion criteria and body weight last menses query if applicable and AE assessment Participants will be queried about compliance with study instructions and changes to habitual lifestyle diet and alcohol consumption Participants will then complete all study procedures outlined in Visit 2 except for randomization The same timing and volume of water consumed at Visit 2 will be replicated at Visit 3 The same lunch items and quantity consumed at Visit 2 will be replicated at Visit 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None