Anti-Inflammatory Milk Matrix

Not Applicable

Recruiting

• Conditions: Obesity; Skeletal Muscle; Inflammation
• Interventions: Behavioral: Controlled-Feeding Intervention; Other: Full-fat milk; Dietary Supplement: Non-dairy beverage; Other: Fat-free milk

• Registration Number: NCT04216004
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-02-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full-fat dairy	Controlled-Feeding Intervention	3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
Full-fat dairy	Full-fat milk	3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
Non-fat diary	Controlled-Feeding Intervention	3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk.
Non-dairy control	Non-dairy beverage	3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk.
Non-dairy control	Controlled-Feeding Intervention	3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk.
Non-fat diary	Fat-free milk	3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk.

Primary Outcome Measures

Name	Time	Method
Blood inflammation markers by flow cytometry.	1 week observation period to respective Arm within a controlled-feeding intervention.	Measurement of blood cytokines, monocytes, and macrophages by flow cytometry before and after 1-week of 3 daily servings of respective dairy treatment within a controlled-feeding intervention.
Fractional synthetic rate of myofibrillar proteins by stable isotope infusion.	0-5 hours postprandial observation period to ingesting 2 servings of respective Arm.	Refers to rate of building new proteins in skeletal muscle contractile protein fraction. Myofibrillar protein synthesis rates will be assessed during stable isotope infusion whereby participants will ingest 2 servings of their respective dairy treatment and the postprandial response is compared between the Arms.

Trial Locations

Locations (1)

Freer Hall; 🇺🇸 Urbana, Illinois, United States