Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04100200
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2019-09-18
Brief Title:
Berries Inflammation and Gut Microbiome
Sponsor:
Clinical Nutrition Research Center Illinois Institute of Technology
Organization:
Clinical Nutrition Research Center Illinois Institute of Technology
Study Overview
Official Title:
Polyphenols and Human Gut Microbiome Interactions Role of in Ameliorating Inflammation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives are to characterize changes in indices of systemic and gut inflammation assess host- and microbial-derived metabolite pools and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute 24hr and chronic 4 week intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet negative control FOS positive control non-polyphenol carbohydrate-based fermentable fiberpre-biotic or combination diet berry composite FOS in human participants with low-grade inflammation
Detailed Description:
The proposed study will be conducted in humans according to Good Clinical Practice GCP guidelines All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technologys Institutional Review Boards IRB prior to screening
This is a single-center randomized single-blinded 4-arm placebo-controlled clinical trial It features an acute single exposure 24-h protocol and a chronic 4-week daily intake protocol to evaluate the effects of anthocyanins and ellagitannins from strawberry and red raspberry intake compared to a control diet FOS or FOS and berries combined on gut inflammation in adults with chronic low-grade inflammation
A planned sample size of 88 will be enrolled in the study This study will require one initial screening visit a pre-study visit and 5 study visits This study will take 5 weeks per subject to complete
The initial screening visit will provide subject with their site-specific IRB-approved informed consent document prior to the start of any study-related procedures Subject eligibility will be determined through a high sensitivity C-Reactive Protein hs-CRP marker value anthropometric measurements vital signs fasting blood glucose test finger prick and completion of a survey related to general eating health mood and exercise habits
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation although stricter guidelines will be imposed during the 3 days prior to a study visit that involved bloodurinefecal collection Shopping lists and meal plans will be provided to subjects along with counseling by the investigators study investigators to help subjects adhere to the limited polyphenolic diet The trial will initiate with a 3-day food diary to assess background pre-study dietary intake followed by counseling to follow a diet relatively low in polyphenolic rich-beveragesfoods which will be maintained for the duration of the experiment After an initial 7-day wash-in period on the limited polyphenolic diet subjects will be randomized to 1 of 4 treatment sequences in the form of a drink a mixed berries diet raspberries and strawberries a FOS diet non-polyphenol carbohydrate-based fermentable fiberpre-biotic a combination diet mixed berries FOS or a control diet negative control Subjects will receive the same treatment for the duration of the study Treatment codes will be maintained by the principal investigator
Each visit will last 2 hours and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit Fasting blood samples will be collected at the 0 and 24h time points via a butterfly needle placed by a certified phlebotomist
This is a single-center randomized single-blinded 4-arm placebo-controlled clinical trial It features an acute single exposure 24-h protocol and a chronic 4-week daily intake protocol to evaluate the effects of anthocyanins and ellagitannins from strawberry and red raspberry intake compared to a control diet FOS or FOS and berries combined on gut inflammation in adults with chronic low-grade inflammation
A planned sample size of 88 will be enrolled in the study This study will require one initial screening visit a pre-study visit and 5 study visits This study will take 5 weeks per subject to complete
The initial screening visit will provide subject with their site-specific IRB-approved informed consent document prior to the start of any study-related procedures Subject eligibility will be determined through a high sensitivity C-Reactive Protein hs-CRP marker value anthropometric measurements vital signs fasting blood glucose test finger prick and completion of a survey related to general eating health mood and exercise habits
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation although stricter guidelines will be imposed during the 3 days prior to a study visit that involved bloodurinefecal collection Shopping lists and meal plans will be provided to subjects along with counseling by the investigators study investigators to help subjects adhere to the limited polyphenolic diet The trial will initiate with a 3-day food diary to assess background pre-study dietary intake followed by counseling to follow a diet relatively low in polyphenolic rich-beveragesfoods which will be maintained for the duration of the experiment After an initial 7-day wash-in period on the limited polyphenolic diet subjects will be randomized to 1 of 4 treatment sequences in the form of a drink a mixed berries diet raspberries and strawberries a FOS diet non-polyphenol carbohydrate-based fermentable fiberpre-biotic a combination diet mixed berries FOS or a control diet negative control Subjects will receive the same treatment for the duration of the study Treatment codes will be maintained by the principal investigator
Each visit will last 2 hours and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit Fasting blood samples will be collected at the 0 and 24h time points via a butterfly needle placed by a certified phlebotomist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None