Anti-Inflammatory Milk Matrix (AIMM)

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: Inflammation; Obesity; Skeletal Muscle

Treatments: Other: Fat-free milk; Behavioral: Controlled-Feeding Intervention; Other: Full-fat milk; Dietary Supplement: Non-dairy beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT04216004

20173

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 40 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups, including a placebo group

Full-fat dairy

Experimental group

Description:

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

Treatment:

Behavioral: Controlled-Feeding Intervention

Other: Full-fat milk

Non-fat diary

Active Comparator group

Description:

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

Treatment:

Other: Fat-free milk

Behavioral: Controlled-Feeding Intervention

Non-dairy control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Controlled-Feeding Intervention

Dietary Supplement: Non-dairy beverage