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A Trial to Assess Full-fat or Low-fat Dairy Foods on Insulin Sensitivity, RBC FA's and Other Markers of Metabolic Health

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 74 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject is 18-74 years of age, inclusive. 2. Subject has a BMI of 25.00 kg/m2 to 39.99 kg/m2 at screening (visit 1b). 3. 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). 4. Subject has a rating of 7 to 10 on the Vein Access Scale at screening (visit 1b; Appendix 2). 5. Subject is judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests. 6. 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. 7. 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. 8. Subject is willing to refrain from using marijuana and consuming alcoholic beverages for 24 h prior to each clinic visit. 9. Subject is willing to consume study-related foods and follow the dietary instructions throughout the 12-week treatment period. 10. Subject is willing to come to the clinic for study food pick-up(s) if needed. 11. Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.

Exclusion Criteria:

1. Subject has a laboratory test result of clinical significance at screening (visit 1b). 2. Subject has fasting blood glucose ≥126 mg/dL at screening (visit 1a) or known type 1 or type 2 diabetes mellitus. 3. 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). 4. 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. 5. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening (visit 1b). 6. Subject has a history of cancer in the prior 5 years, except for non-melanoma skin cancer or carcinoma in situ of the cervix. 7. Subject has experienced a change in body weight of ±4.5 kg (10 pounds) over the 3 months prior to screening (visit 1b). 8. Subject has unstable use (initiation or dose alteration) of any antihypertensive medication within 4 weeks prior to screening (visit 1b). 9. 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. 10. 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). 11. Subject has unstable use (initiation or dose alteration) of weight-loss drugs (including over-the-counter medications and/or supplements) and/or systemic corticosteroid drugs within 4 weeks of screening (visit 1b). 12. Subject has unstable use (initiation or dose alteration) of medications known to influence carbohydrate metabolism, including, but not limited to: adrenergic receptor blockers, thiazide diuretics, hypoglycemic medications, and/or antipsychotics within 4 weeks prior to screening (visit 1b). 13. Subject has an active infection or has used antibiotics within 5 d of any clinic visit. Those with an active infection and/or using antibiotics must wait at least 5 d after the infection resolves or antibiotic use is complete. The test period will be extended for completion in these cases. 14. Subject has a known allergy, sensitivity, or intolerance to any ingredients in the study foods. Mild lactose intolerance is not exclusionary. 15. Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. 16. Subject has extreme dietary habits (e.g., vegan or very low carbohydrate diet). 17. Subject has a current or recent history (past 12 months), or strong potential, for drug or alcohol abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1 ½ oz distilled spirits). 18. Subject has a history of a diagnosed eating disorder (e.g., anorexia nervosa or bulimia nervosa). 19. Subject has been exposed to any non-registered drug product within 30 d of screening (visit 1b). 20. Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04999462
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Midwest Center for Metabolic and Cardiovascular Research
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kevin Maki, PhD
Principal Investigator Affiliation MB Clinical Research & Consulting, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Overweight and Obesity, Elevated Triglycerides
Arms & Interventions

Arms

Experimental: Full-fat fermented dairy

1 serving per day of full-fat yogurt and full-fat fermented cheese

Active Comparator: Low-fat fermented dairy

1 serving per day of low-fat yogurt and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese).

Placebo Comparator: Non-dairy, non-fermented foods

2 servings per day of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition.

Interventions

Other: - Full-fat fermented dairy

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.

Other: - Low-fat fermented dairy

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).

Other: - Non-dairy, non-fermented foods

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Excellence Medical and Research, Miami Gardens, Florida

Status

Address

Excellence Medical and Research

Miami Gardens, Florida, 33169

Illinois Institute of Technology, Chicago, Illinois

Status

Address

Illinois Institute of Technology

Chicago, Illinois, 60616

Great Lakes Clinical Trials, Chicago, Illinois

Status

Address

Great Lakes Clinical Trials

Chicago, Illinois, 60640

Great Lakes Clinical Trials, Gurnee, Illinois

Status

Address

Great Lakes Clinical Trials

Gurnee, Illinois, 60031

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