Recruiting

Anti-Inflammatory Milk

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT04216004

Conditions

Obesity

Skeletal Muscle

Inflammation

Eligibility Criteria

Sex: All

Age: 40 - 59

Healthy Volunteers: Accepted

Interventions

Controlled-Feeding Intervention

Non-dairy beverage

Full-fat milk

Fat-free milk

Study Details

Brief 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.

Conditions

Obesity

Skeletal Muscle

Inflammation

Study ID

NCT04216004

Start date

Feb 14, 2020

Status verified date

May, 2023

Completion date

Mar, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 59

Healthy Volunteers: Accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Full-fat dairy

3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.

active comparator: Non-fat diary

3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk.

placebo comparator: Non-dairy control

3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk.

Interventions

Controlled-Feeding Intervention

All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.

Non-dairy beverage

Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.

Full-fat milk

3 daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.

Fat-free milk

3 daily servings (cup-eq) of fat-free (0%) commercial cow's milk.

Primary outcome measure

  • Fractional synthetic rate of myofibrillar proteins by stable isotope infusion. [ Time Frame: 0-5 hours postprandial observation period to ingesting 2 servings of respective Arm. ]
  • Blood inflammation markers by flow cytometry. [ Time Frame: 1 week observation period to respective Arm within a controlled-feeding intervention. ]

Central Contacts and Locations

Central contacts

Nicholas A Burd, Ph.D.

217-244-0970naburd@illinois.edu

Locations

Freer Hall

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Nicholas A Burd, Ph.D.

217-244-0970naburd@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

May 9, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2023-05-09.