Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611215
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Effect of a Nutritional Supplement on Gut Microbiota in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double Blind Placebo-controlled Parallel Study to Investigate the Effect of Prebiotic Supplements on Gut Microbiota Modulation and Quality of Life
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
According to International Scientific Association for Probiotics and Prebiotics ISAPP a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit Gibson et al 2017 Fibers Prebiotics are known to have several beneficial effects on human health via gut They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses
Detailed Description:
This is a 4 arm randomized placebo-controlled double-blind parallel study which will be conducted remotely and will include 4 visits over 10 week period - a screening visit Visit 1 week -2 a 2-week run-in period followed by baseline determination or baseline visit Visit 2 day 0 and two test visits Visits 3 and 4 at days 28 and 56 respectively
SCREENING Visit 1 - Week -2
At Visit 1 Screening visit Participants will attend the study site and the following procedures will be carried out
Participants will receive oral and written information about the study and be allowed to ask questions
Participants will sign the informed consent document
Inclusion and exclusion criteria will be reviewed
Demographic health and lifestyle data will be collected
Medical history will be collected
Concomitant medication will be recorded
Height and weight will be collected Body Mass Index BMI calculated
Complete Block Fiber screener
Participants will be given an appointment to return to the study site within 14 days for their baselineday 1 visit
INTERVENTION PHASE Visit 2 - Week 0
Participants will attend this study visit and the following procedures will be carried out
Participants continued consent to study procedures will be confirmed
Inclusionexclusion criteria will be reviewed
Adverse events will be recorded
Concomitant medicationsupplements will be recorded
Weight will be measured and BMI calculated
Participants will return their saliva samples and samples will be stored for future analysis
Participants will return their stool sample and sample will be stored for future analysis
Participants will have completed the following questionnaires within 24 hours of the visit
36 item short form survey SF-36
Participants will be randomized into one of two treatment groups as follows but will be blinded as to which group they are in
Group 1 Prebiotic 1
Group 2 Placebo 1
Group 3 Prebiotic 2
Group 4 Placebo 2
Participants will be supplied with an 8-week supply of study product and instructions of dosing Participants will be instructed to take one stick pack each day for the next eight weeks An additional eight four days of doses will be supplied in case of delay of study visit or loss of study product
- Participants will be provided with an appointment to return to the study site in four weeks
Visit 3 - Week 4
Participants will return for virtual visit
Participants continued consent to study procedures will be confirmed
Adverse events will be recorded
Concomitant medicationsupplements will be recorded
Weight will be measured and BMI calculated
Participants will return their saliva samples and samples will be stored for future analysis
Participants will return their stool sample and sample will be stored for future analysis
- Participants will have completed the following questionnaires within 24 hours of the visit
36 item short form survey SF-36
Participants will be provided with an appointment to return to the study site in four weeks
Visit 4 Final Visit - Week 8
Participants will return to the study site at day 56 and the following procedures will be carried out
Adverse events will be recorded
Concomitant medicationsupplements will be recorded
Participants will return any unused study product and compliance will be assessed
Participants will return their saliva samples and samples will be stored for future analysis
Participants will return their stool sample and sample will be stored for future analysis
Participants will return their 3-day food diary
Weight will be measured and BMI calculated
Participants will have completed the following questionnaires within 24 hours of the visit
36 item short form survey SF-36
SCREENING Visit 1 - Week -2
At Visit 1 Screening visit Participants will attend the study site and the following procedures will be carried out
Participants will receive oral and written information about the study and be allowed to ask questions
Participants will sign the informed consent document
Inclusion and exclusion criteria will be reviewed
Demographic health and lifestyle data will be collected
Medical history will be collected
Concomitant medication will be recorded
Height and weight will be collected Body Mass Index BMI calculated
Complete Block Fiber screener
Participants will be given an appointment to return to the study site within 14 days for their baselineday 1 visit
INTERVENTION PHASE Visit 2 - Week 0
Participants will attend this study visit and the following procedures will be carried out
Participants continued consent to study procedures will be confirmed
Inclusionexclusion criteria will be reviewed
Adverse events will be recorded
Concomitant medicationsupplements will be recorded
Weight will be measured and BMI calculated
Participants will return their saliva samples and samples will be stored for future analysis
Participants will return their stool sample and sample will be stored for future analysis
Participants will have completed the following questionnaires within 24 hours of the visit
36 item short form survey SF-36
Participants will be randomized into one of two treatment groups as follows but will be blinded as to which group they are in
Group 1 Prebiotic 1
Group 2 Placebo 1
Group 3 Prebiotic 2
Group 4 Placebo 2
Participants will be supplied with an 8-week supply of study product and instructions of dosing Participants will be instructed to take one stick pack each day for the next eight weeks An additional eight four days of doses will be supplied in case of delay of study visit or loss of study product
- Participants will be provided with an appointment to return to the study site in four weeks
Visit 3 - Week 4
Participants will return for virtual visit
Participants continued consent to study procedures will be confirmed
Adverse events will be recorded
Concomitant medicationsupplements will be recorded
Weight will be measured and BMI calculated
Participants will return their saliva samples and samples will be stored for future analysis
Participants will return their stool sample and sample will be stored for future analysis
- Participants will have completed the following questionnaires within 24 hours of the visit
36 item short form survey SF-36
Participants will be provided with an appointment to return to the study site in four weeks
Visit 4 Final Visit - Week 8
Participants will return to the study site at day 56 and the following procedures will be carried out
Adverse events will be recorded
Concomitant medicationsupplements will be recorded
Participants will return any unused study product and compliance will be assessed
Participants will return their saliva samples and samples will be stored for future analysis
Participants will return their stool sample and sample will be stored for future analysis
Participants will return their 3-day food diary
Weight will be measured and BMI calculated
Participants will have completed the following questionnaires within 24 hours of the visit
36 item short form survey SF-36
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