Anti-Inflammatory Milk Matrix

Obesity Clinical Trial

— AIMM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216004
• Other study ID #: 20173
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: Nicholas A Burd, Ph.D.
• Phone: 217-244-0970
• Email: naburd[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Skeletal Muscle

Intervention

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

Locations

Country	Name	City	State
United States	Freer Hall	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.