The objectives of this trial are to assess the effects of adding 2 servings/d of either full-fat or low-fat fermented dairy products to the diet, as a replacement for non-dairy foods with macronutrient composition similar to the low-fat fermented dairy condition, on insulin sensitivity, erythrocyte fatty acid profile and other cardiometabolic health markers in metabolically at-risk adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
110
Subjects assigned to the full-fat fermented dairy condition will consume 1 serving/d each of full-fat yogurt (plain or reduced sugar varieties) and full-fat fermented cheese.
Subjects assigned to the low-fat fermented dairy condition will consume 1 serving/d each of low-fat yogurt (plain or reduced sugar varieties) and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese).
Subjects assigned to the control condition will consume 2 servings/d of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition.
Excellence Medical and Research
Miami Gardens, Florida, United States
Illinois Institute of Technology
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Great Lakes Clinical Trials
Gurnee, Illinois, United States
Insulin Sensitivity
The percent change from baseline to the end of treatment at 12 weeks in the Matsuda index
Time frame: 12 weeks
Carbohydrate metabolism variables
Changes or percent changes from baseline to the end of treatment of fasting glucose and insulin, liquid meal tolerance test (LMTT) disposition index and homeostasis model assessments of pancreatic beta-cell function (HOMA2%B) and insulin sensitivity (HOMA2%S).
Time frame: 12 weeks
Lipid variables
Changes or percent changes from baseline to end of treatment of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, TG; lipoprotein particle concentrations and subfractions.
Time frame: 12 weeks
Erythrocyte
Changes or percent changes from baseline to the end of treatment of Erythrocyte 15:0, 17:0 and 1-16:1n-7 content (expressed as % of total fatty acids)
Time frame: 12 weeks
High-sensitivity C-reactive proten (hs-CRP)
Changes or percent changes from baseline to the end of treatment
Time frame: 12 weeks
Waist circumference
Changes or percent changes from baseline to the end of treatment
Time frame: 12 weeks
Seated, resting systolic and diastolic blood pressures and heart rate
Changes or percent changes from baseline to the end of treatment
Time frame: 12 weeks
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Alternate Healthy Eating Index
Changes or percent changes from baseline to the end of treatment
Time frame: 12 weeks