The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice daily on insulin sensitivity and markers of cardiometabolic health in men and women with prediabetes.
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, 1.5 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, medication/supplement 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
54
1.5 oz of whole, natural almonds
Low-fat foods, high in refined starches and added sugars
MB Clinical Research
Boca Raton, Florida, United States
Illinois Institute for Food Safety and Health (IFSH) at Illinois Instiute of Technology (IIT)
Chicago, Illinois, United States
Insulin sensitivity index (SI)
SI from a short (50-min) intravenous glucose tolerance test (IVGTT) at baseline(day 0) and end of two treatment periods (day 43 of both treatment periods)
Time frame: 43 days for each treatment period.
Fasting lipoprotein lipids
Fasting blood samples will be collected for measurements of lipoprotein lipids including: Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non HDL-C, TC/HDL-C ratio and triglycerides (TG) at all visits.
Time frame: Up to 43 days for each treatment period.
Apolipoprotein (Apo) B and A1, Lipoprotein subfractions and particles
Fasting blood samples will be collected for measurements of Apo B1 and A1, and lipoprotein subfractions and particles at baseline (day 0) and end of the two treatment periods (day 43)
Time frame: 43 days for each treatment period
high-sensitivity C-reactive protein (hs-CRP)
Fasting blood samples will be collected for measurement of hs-CRP at all visits.
Time frame: Up to 43 days
Serum Uric acid
Fasting blood samples will be collected to measure serum Uric acid levels at the beginning and end of each treatment periods.
Time frame: 43 days for each treatment period
Interleukin-6 (IL-6)
Fasting blood samples will be collected to measure serum IL-6 levels at baseline (day 0) and the end of the two treatment periods (day 43)
Time frame: 43 days for each treatment period
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