Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03126981
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2017-04-20
Brief Title:
Effects of Almonds on Insulin Sensitivity in Prediabetes
Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Organization:
Midwest Center for Metabolic and Cardiovascular Research
Study Overview
Official Title:
A Randomized Crossover Trial to Assess the Effects of Replacing Refined Carbohydrates With Almonds on Insulin Sensitivity in Men and Women With Prediabetes
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The goal of this clinical trial is to evaluate the effects of consuming 15 oz almonds twice daily on insulin sensitivity and markers of cardiometabolic health in men and women with prediabetes
Detailed Description:
This is a randomized controlled two-period crossover study that includes two screening visits and two 6-week test periods separated by a 4-week washout Subjects consume twice daily 15 oz whole natural almonds Active Condition or low-fat foods high in refined starches and added sugars matched for energy content to the almonds Control Condition The assigned study products will be dispensed with instructions to consume 2 servings Active Product or 3 servings Control Products each day starting on day 1 Subjects will be screened for prediabetes at the first screening visits An intravenous glucose tolerance test IVGTT will be completed at baseline and the end of each treatment period Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein hs-CRP measurements at all visits Additionally blood will be drawn for measurement of Apolipoprotein B and A1 lipoprotein particles and subfractions Interleukin 6 IL-6 and Uric acid at the beginning and the end of each test period Assessments of vital signs body weight evaluation of inclusion and exclusion criteria medicationsupplement use and adverse effects will be performed throughout the study Compliance will be assessed through a daily log record and return of unopened study product
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