CompletedNot Applicable

Full-fat Yogurt and Glucose Tolerance

United States13 participantsStarted 2018-06-01

Plain-language summary

This study determines if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can reduce the risk of type 2 diabetes and inflammation in association with changes in the composition of the gastrointestinal bacteria prediabetic male and female volunteers. The central hypothesis is that dairy fat impacts whole body glucose handling and insulin sensitivity as well as inflammation both directly, and indirectly via influencing the gut microbiota composition.

Who can participate

Age range

45 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women and not expecting major lifestyle changes while on study * Age 45-75 * Overweight and obesity (BMI 20-45 kg/m2) * Stable body weight for the last 6 months (no more than a +/- 5% change) * Diagnosis of prediabetes, defined as either impaired fasting glucose (fasting glucose: 100-125 mg/dL), impaired glucose tolerance (blood glucose levels of between: 140-199 mg/dL 2-hr post 75-g oral glucose tolerance test), and/or a hemoglobin A1C (HbA1C) level ranging from 5.7% to 7.0% (if HbA1C above 6.4%, monotherapy of Metformin) * Women: Post-Menopausal: no menses previous 12 mos.; Follicular Stimulating Hormone (FSH) \> 20 mIU/mL * Consuming at least 25% of calories from fat (screening will be based an online fat screener: http://nutritionquest.com/wellness/free-assessment-tools-for-individuals/fat-intake-screener/ * Normal cognition * Read and understand English * Have a telephone * Willing to follow the study coordinator's/manager's and dietitian's instructions Exclusion Criteria: * Fasting blood glucose ≥126 mg/dL, HbA1C ≥7.0% without monotheraoy of Metformin * Subject with any chronic disease, inflammatory disease (e.g., asthma, rheumatoid arthritis, Crohn's disease or inflammatory bowel disease) and previous diagnosis of HIV or hepatitis C * Pregnant or breastfeeding women or women on hormone replacement therapy (for previous 3 months) * Intolerance to dairy foods (i.e., lactose intolerance or protein allergy), food allergies, or significant…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in insulin sensitivity and β-cell function: MMTT

Timeframe: Baseline, 4 weeks, and 8 weeks

Changes in insulin sensitivity and β-cell function: OGTT

Timeframe: Baseline, 4 weeks, and 8 weeks

Trial details

NCT IDNCT03577119

SponsorUniversity of Vermont Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-30

View on ClinicalTrials.gov More Pre-Diabetes trials