Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544954
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing Prebiotic Effect of California Grape Consumption on Gut Microbiome and Impact on Intestinal Permeability Vascular Function and Systemic Inflammation in Over-weight Subjects Differences in Effects Between Men and Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
CALGRAM
Brief Summary:
The goal of this clinical trial is to assess the impact of table grape consumption on gut microbiome intestinal permeability systemic inflammation and vascular function in healthy overweight men and women aged 45-70 years The main questions it aims to answer are
Does daily grape intake alter intestinal microbiome composition and intestinal permeability
Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors inflammation vascular function lipid profiles
Does response to grape intake on gut microbiota intestinal permeability cardiometabolic and inflammatory markers differ between men and women
Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors
Researchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors
Participants will
Consume the powder dissolved in water twice daily for 4 weeks
Follow their usual diet modified to limit polyphenol-rich foods
Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection
Complete a 3-day dietary recall and collect stool sample before each visit
Does daily grape intake alter intestinal microbiome composition and intestinal permeability
Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors inflammation vascular function lipid profiles
Does response to grape intake on gut microbiota intestinal permeability cardiometabolic and inflammatory markers differ between men and women
Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors
Researchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors
Participants will
Consume the powder dissolved in water twice daily for 4 weeks
Follow their usual diet modified to limit polyphenol-rich foods
Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection
Complete a 3-day dietary recall and collect stool sample before each visit
Detailed Description:
Participants will limit intake of grapes and other polyphenol-rich foods while following their usual diet during the 3-day run-in period before the start of the intervention They will be randomized to start with either grape or placebo powder for 4 weeks consuming 40 grams of freeze-dried grape powder or placebo dissolved in water twice daily Compliance will be assessed with three 24-hour dietary recalls using ASA24 and follow-up contact After a 4-week washout period participants will crossover to the other intervention Study outcomes and anthropometry will be measured on the first and last days of each intervention arm
Aim 1 Biomarkers to assess the permeability of the gut including zonulin lipopolysaccharide LPS LPS-binding protein LBP soluble CD14 and diamine oxidase DAO will be analyzed from blood samples Gut microbiome profiling will be analyzed from 16S rRNA gene sequencing of fecal samples collected by participants at the beginning and end of each intervention arm
Aim 2 Vascular function will be assessed by measuring blood pressure and pulse wave velocity After 15 minutes of rest blood pressure will be measured three times with the average of the latter two recorded Pulse wave velocity from the carotid to femoral artery will measure arterial stiffness Inflammatory cytokines will be assayed from blood samples to include Th17 cytokines Lipid panel and comprehensive metabolic panels will also be analyzed
Aim 3 Sex differences in response to grape consumption will be assessed including gut microbiome gut permeability vascular function inflammation lipid profile and metabolomic pathways Gender and time interactions will be determined to assess differences in trajectory of changes
Aim 4 LC-MS will be used for untargeted metabolomics and lipidomics Pathway analysis will assess metabolic pathways affected by grape consumption and their links to gut permeability systemic inflammation and vascular function
Aim 1 Biomarkers to assess the permeability of the gut including zonulin lipopolysaccharide LPS LPS-binding protein LBP soluble CD14 and diamine oxidase DAO will be analyzed from blood samples Gut microbiome profiling will be analyzed from 16S rRNA gene sequencing of fecal samples collected by participants at the beginning and end of each intervention arm
Aim 2 Vascular function will be assessed by measuring blood pressure and pulse wave velocity After 15 minutes of rest blood pressure will be measured three times with the average of the latter two recorded Pulse wave velocity from the carotid to femoral artery will measure arterial stiffness Inflammatory cytokines will be assayed from blood samples to include Th17 cytokines Lipid panel and comprehensive metabolic panels will also be analyzed
Aim 3 Sex differences in response to grape consumption will be assessed including gut microbiome gut permeability vascular function inflammation lipid profile and metabolomic pathways Gender and time interactions will be determined to assess differences in trajectory of changes
Aim 4 LC-MS will be used for untargeted metabolomics and lipidomics Pathway analysis will assess metabolic pathways affected by grape consumption and their links to gut permeability systemic inflammation and vascular function
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