Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339879
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-12-11
Brief Title:
Health Effects of Grain Foods in Adults
Sponsor:
Purdue University
Organization:
Purdue University
Study Overview
Official Title:
Health Effects of Grain Foods in Adults
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics appetite foodenergy intake body weight blood pressure acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars saturated fats and sodium
Detailed Description:
This 16-week randomized controlled parallel-arm clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics appetite foodenergy intake body weight and blood pressure as well as acute and longer-term glycemia and lipemia It will also examine the effects of foods varying in graincarbohydrate composition on the microbiome and microbiota functionality One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups These groups will be defined by the diets they are prescribed All will be prescribed diets containing approximately 50 35 and 15 energy from carbohydrate fat and protein respectively Grain foods will comprise 50 of the carbohydrate component ie 25 of total energy The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars The grain foods meeting these criteria will have the following composition
Group 1 - High Whole Grain Low Sugar 6 servings of whole grain and 13 energy from added sugars
Group 2 - Low Whole Grain Low Sugar 3 servings of whole grain and 13 energy from added sugars
Group 3 - High Whole Grain High Sugar 6 servings of whole grain and 13 energy from added sugars
Group 4 - Low Whole Grain High Sugar 3 servings of whole grain and 13 energy from added sugars
Detailed Study Design
The study measures and timing are outlined in the following table
Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics palatability X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT Meal Tolerance Test DXA Dual-energy X-ray Absorptiometry CGMContinuous glucose monitoring
Group 1 - High Whole Grain Low Sugar 6 servings of whole grain and 13 energy from added sugars
Group 2 - Low Whole Grain Low Sugar 3 servings of whole grain and 13 energy from added sugars
Group 3 - High Whole Grain High Sugar 6 servings of whole grain and 13 energy from added sugars
Group 4 - Low Whole Grain High Sugar 3 servings of whole grain and 13 energy from added sugars
Detailed Study Design
The study measures and timing are outlined in the following table
Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics palatability X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT Meal Tolerance Test DXA Dual-energy X-ray Absorptiometry CGMContinuous glucose monitoring
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