UnknownNot Applicable

Anti-Inflammatory Milk Matrix

United States36 participantsStarted 2020-02-14

Plain-language summary

Obesity is pro-inflammatory, impairs metabolism, and physically limiting. Specifically, muscle in obese persons does not synthesize proteins normally. This further increases metabolic and physical dysfunction. As such, obesity programs should not only focus on weight loss, but muscle metabolic health. Dairy nutrients have anti-inflammatory and anabolic properties, but mostly evaluated in isolation and/or pre-clinical designs. Also, it is unknown if the circulating benefits extend to the muscle. We hypothesize that dairy full-fat milk will improve these obesity characteristics.

Who can participate

Age range

40 Years – 59 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: * Obese (BMI, body mass index ≥30, \<40 kg•m-2) * Age 40-59 * Pre-menopausal * Sedentary/insufficiently active for prior 6 months (mo) * Weight stable for prior 6 mo Exclusion Criteria: * Tobacco, nicotine (patch/gum) use (previous 6 mo) * Alcohol consumption \>10 drinks per week * Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases) * Cardiovascular disease, arrhythmias * Hypogonadism * Asthma * History of uncontrolled hypertension * Orthopedic injury/surgery (within 1 yr) * Hepatorenal, musculoskeletal, autoimmune, or neurological disease * History of neuromuscular problems * Previous participation in amino acid tracer studies * Predisposition to hypertrophic scarring or keloid formation * Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation * Consumption of thyroid, androgenic, or other medications known to affect endocrine function * Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication) * Pregnancy * Allergy to dairy product or lactose intolerance * Fasting plasma glucose (FPG) ≥ 126 mg/dL * Oral glucose tolerance test (OGTT) ≥ 200 mg/dL

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

Fractional synthetic rate of myofibrillar proteins by stable isotope infusion.

Timeframe: 0-5 hours postprandial observation period to ingesting 2 servings of respective Arm.

Blood inflammation markers by flow cytometry.

Timeframe: 1 week observation period to respective Arm within a controlled-feeding intervention.

Trial details

NCT IDNCT04216004

SponsorUniversity of Illinois at Urbana-Champaign

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Nicholas A Burd, Ph.D.

217-244-0970 naburd@illinois.edu

View on ClinicalTrials.gov More Obesity trials