Anti-Inflammatory Milk Matrix (AIMM)

Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Obesity; Skeletal Muscle
• Intervention / Treatment: Behavioral: Controlled-Feeding Intervention; Other: Full-fat milk; Other: Fat-free milk; Dietary supplement: Non-dairy beverage

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas A Burd, Ph.D.; Phone Number: 217-244-0970; Email: naburd@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • Freer Hall
      • Contact: Nicholas A Burd, Ph.D.; Phone Number: 217-244-0970; Email: naburd@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full-fat dairy; 3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.	Behavioral: Controlled-Feeding Intervention; All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.; Other: Full-fat milk; 3 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.	Behavioral: Controlled-Feeding Intervention; All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.; Other: Fat-free milk; 3 daily servings (cup-eq) of fat-free (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.	Behavioral: Controlled-Feeding Intervention; All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.; Dietary supplement: Non-dairy beverage; Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 20173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No