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

NCT04999462 | Completed

• 1 other identifier: MB-1913
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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.

Conditions

Overweight and Obesity; Elevated Triglycerides

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  The percent change from baseline to the end of treatment at 12 weeks in the Matsuda index

  12 weeks

Secondary Outcomes (7)

• Carbohydrate metabolism variables

  12 weeks

• Lipid variables

  12 weeks

• Erythrocyte

  12 weeks

• High-sensitivity C-reactive proten (hs-CRP)

  12 weeks

• Waist circumference

  12 weeks

Study Arms (3)

Full-fat fermented dairy

EXPERIMENTAL

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

Other: Full-fat fermented dairy

Low-fat fermented dairy

ACTIVE COMPARATOR

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

Other: Low-fat fermented dairy

Non-dairy, non-fermented foods

PLACEBO COMPARATOR

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

Other: Non-dairy, non-fermented foods

Interventions

Full-fat fermented dairy OTHER

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.

Full-fat fermented dairy

Low-fat fermented dairy OTHER

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).

Low-fat fermented dairy

Non-dairy, non-fermented foods OTHER

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.

Non-dairy, non-fermented foods

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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).
• 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).
• 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.
• 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.
• Subject has extreme dietary habits (e.g., vegan or very low carbohydrate diet).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• National Dairy Council: collaborator

Study Sites (4)

Excellence Medical and Research

Miami Gardens, Florida, 33169, United States

Location

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Great Lakes Clinical Trials

Gurnee, Illinois, 60031, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Kevin Maki, PhD

  MB Clinical Research & Consulting, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 10, 2021
• Study Start: September 15, 2021
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)