Overweight and ObesityNCT04999462
A Trial to Assess Full-fat or Low-fat Dairy Foods on Insulin Sensitivity, RBC FA's and Other Markers of Metabolic Health
A study testing Full-fat fermented dairy, Low-fat fermented dairy and Non-dairy, non-fermented foods in people with Overweight and Obesity and Elevated Triglycerides, run by Midwest Center for Metabolic and Cardiovascular Research at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Elevated Triglycerides
- What is being tested?
- Full-fat fermented dairy, Low-fat fermented dairy and Non-dairy, non-fermented foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2021to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 has a known allergy, sensitivity, or intolerance to any ingredients in the study foods. Mild lactose intolerance is not exclusionary.
- 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).
- 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).
- Subject has a history of a diagnosed eating disorder (e.g., anorexia nervosa or bulimia nervosa).
- Subject has been exposed to any non-registered drug product within 30 d of screening (visit 1b).
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Illinois Institute of Technology
Chicago, Illinois, 60616
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Great Lakes Clinical Trials
Gurnee, Illinois, 60031
Excellence Medical and Research
Miami Gardens, Florida, 33169
About this study
Official title: 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
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
- Being tested
- Full-fat fermented dairy, Low-fat fermented dairy, Non-dairy, non-fermented foods
- Medical subject headings
- Overweight, Obesity, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-fat fermented dairyOther
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.
Low-fat fermented dairyOther
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).
Non-dairy, non-fermented foodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Full-fat fermented dairy | Experimental | 1 serving per day of full-fat yogurt and full-fat fermented cheese Receives: 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). Receives: 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. Receives: Other: Non-dairy, non-fermented foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
The percent change from baseline to the end of treatment at 12 weeks in the Matsuda index
Measured: 12 weeks
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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)
Measured: 12 weeks
High-sensitivity C-reactive proten (hs-CRP)
Changes or percent changes from baseline to the end of treatment
Measured: 12 weeks
Waist circumference
Changes or percent changes from baseline to the end of treatment
Measured: 12 weeks
Seated, resting systolic and diastolic blood pressures and heart rate
Changes or percent changes from baseline to the end of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Sep 2021
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Study director, MB Clinical Research & Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999462
- Sponsor's protocol ID
- MB-1913
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maki KC, Gletsu-Miller N, Edirisinghe I, Wilcox ML, Adams CG, Palacios OM, Spence LA, Sprague KL, James E, Friedman AN, Guzman E, Burton-Freeman B. A Randomized Controlled Trial to Evaluate the Effects of Full-Fat and Low-Fat Fermented Dairy Foods on Markers of Cardiometabolic Health in Adults with Overweight or Obesity and Elevated Fasting Triglycerides. Curr Dev Nutr. 2026 Aug 14;10(9):109516. doi: 10.1016/j.cdnut.2026.109516. eCollection 2026 Sep.
PubMed 42733680
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04999462
- Acronym / sponsor ID
- MB-1913
- Conditions
- Overweight and Obesity, Elevated Triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-fat fermented dairy | Experimental | Other: Full-fat fermented dairy1 serving per day of full-fat yogurt and full-fat fermented cheese |
| Low-fat fermented dairy | Active comparator | Other: Low-fat fermented dairy1 serving per day of low-fat yogurt and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese). |
| Non-dairy, non-fermented foods | Placebo comparator | Other: Non-dairy, non-fermented foods2 servings per day of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-fat fermented dairySubjects 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 | Full-fat fermented dairy |
| Low-fat fermented dairySubjects 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 | Low-fat fermented dairy |
| Non-dairy, non-fermented foodsSubjects 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. | Other | Non-dairy, non-fermented foods |
Primary outcome
Insulin Sensitivity
Time frame: 12 weeks
The percent change from baseline to the end of treatment at 12 weeks in the Matsuda index
6 secondary outcomes
Carbohydrate metabolism variables
Time frame: 12 weeks
Lipid variables
Time frame: 12 weeks
Erythrocyte
Time frame: 12 weeks
High-sensitivity C-reactive proten (hs-CRP)
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Seated, resting systolic and diastolic blood pressures and heart rate
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42733680Maki KC, Gletsu-Miller N, Edirisinghe I, Wilcox ML, Adams CG, Palacios OM, Spence LA, Sprague KL, James E, Friedman AN, Guzman E, Burton-Freeman B. A Randomized Controlled Trial to Evaluate the Effects of Full-Fat and Low-Fat Fermented Dairy Foods on Markers of Cardiometabolic Health in Adults with Overweight or Obesity and Elevated Fasting Triglycerides. Curr Dev Nutr. 2026 Aug 14;10(9):109516. doi: 10.1016/j.cdnut.2026.109516. eCollection 2026 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Maki, PhD study director
MB Clinical Research & Consulting, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-fat fermented dairy, Low-fat fermented dairy and Non-dairy, non-fermented foods in people with Overweight and Obesity and Elevated Triglycerides, run by Midwest Center for Metabolic and Cardiovascular Research at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.