Anti-Inflammatory Milk Matrix

NCT04216004 | Unknown

• 1 other identifier: 20173
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Fractional synthetic rate of myofibrillar proteins by stable isotope infusion.

  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.

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

• Blood inflammation markers by flow cytometry.

  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.

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

Study Arms (3)

Full-fat dairy

EXPERIMENTAL

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

Behavioral: Controlled-Feeding Intervention; Other: Full-fat milk

Non-fat diary

ACTIVE COMPARATOR

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

Behavioral: Controlled-Feeding Intervention; Other: Fat-free milk

Non-dairy control

PLACEBO COMPARATOR

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

Behavioral: Controlled-Feeding Intervention; Dietary Supplement: Non-dairy beverage

Interventions

Controlled-Feeding Intervention BEHAVIORAL

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

Full-fat dairy; Non-dairy control; Non-fat diary

Non-dairy beverage DIETARY_SUPPLEMENT

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

Non-dairy control

Full-fat milk OTHER

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

Full-fat dairy

Fat-free milk OTHER

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

Non-fat diary

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Nicholas A Burd, Ph.D.

CONTACT

217-244-0970; naburd@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 2, 2020
• Study Start: February 14, 2020
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

US (1)