Anti-Inflammatory Milk Matrix

Overview

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.

Full Title of Study: “Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2023

Interventions

  • 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.
  • Other: Full-fat milk
    • 3 daily servings (cup-eq) of full-fat (3.25%) commercial cow’s milk.
  • Other: Fat-free milk
    • 3 daily servings (cup-eq) of fat-free (0%) commercial cow’s milk.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • 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.
  • Blood inflammation markers by flow cytometry.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Illinois at Urbana-Champaign
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nicholas Burd, Associate Professor – University of Illinois at Urbana-Champaign
  • Overall Contact(s)
    • Nicholas A Burd, Ph.D., 217-244-0970, naburd@illinois.edu

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