A Randomized, Parallel Trial to Assess the Effects of Replacing Non-fermented, Non-dairy Foods With Full-fat or Low-fat Fermented Dairy Foods on Insulin Sensitivity, RBC FA's and Other Markers of Cardiometabolic Health

Midwest Center for Metabolic and Cardiovascular Research3 sites in 1 country110 target enrollmentSeptember 15, 2021

ConditionsOverweight and Obesity Elevated Triglycerides

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight and Obesity
Sponsor: Midwest Center for Metabolic and Cardiovascular Research
Enrollment: 110
Locations: 3
Primary Endpoint: Insulin Sensitivity
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2021

End Date

January 13, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Midwest Center for Metabolic and Cardiovascular Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is 18-74 years of age, inclusive.
•Subject has a BMI of 25.00 kg/m2 to 39.99 kg/m2 at screening (visit 1b).
•Subject has a fasting TG level ≥135 mg/dL at screening (visit 1a), or a fasting TG level 122-134 mg/dL (inclusive) and a fasting venous TG level of ≥135 mg/dL at screening (visits 1a and 1b, respectively).
•Subject has a rating of 7 to 10 on the Vein Access Scale at screening (visit 1b; Appendix 2).
•Subject is judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
•Subject is willing to maintain usual physical activity pattern throughout the study and is willing to refrain from vigorous physical activity for 24 h prior to each clinic visit.
•Subject has no plans to change smoking habits during the study and is willing to abstain from tobacco products and caffeine use 1 h prior to and during each clinic visit.
•Subject is willing to refrain from using marijuana and consuming alcoholic beverages for 24 h prior to each clinic visit.
•Subject is willing to consume study-related foods and follow the dietary instructions throughout the 12-week treatment period.
•Subject is willing to come to the clinic for study food pick-up(s) if needed.

Exclusion Criteria

•Subject has a laboratory test result of clinical significance at screening (visit 1b).
•Subject has fasting blood glucose ≥126 mg/dL at screening (visit 1a) or known type 1 or type 2 diabetes mellitus.
•Subject has atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease \[symptomatic (e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin) or \>50% stenosis on angiography or ultrasound\] or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
•Subject has a history or presence of a clinically important medical condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.
•Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening (visit 1b).
•Subject has a history of cancer in the prior 5 years, except for non-melanoma skin cancer or carcinoma in situ of the cervix.
•Subject has experienced a change in body weight of ±4.5 kg (10 pounds) over the 3 months prior to screening (visit 1b).
•Subject has unstable use (initiation or dose alteration) of any antihypertensive medication within 4 weeks prior to screening (visit 1b).
•Subject has unstable use (initiation or dose alteration) of any of the following lipid-altering medications within 4 weeks prior to screening (visit 1b): statins, ezetimibe, bempedoic acid, bile acid sequestrants, fibrates, niacin (drug form), and/or omega-3 fatty acid drugs.
•Subject has unstable use (initiation or dose alteration) of a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor within 3 months of screening (visit 1b).