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Anti-Inflammatory Milk Matrix (AIMM)

Primary Purpose

Obesity, Skeletal Muscle, Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled-Feeding Intervention
Non-dairy beverage
Full-fat milk
Fat-free milk
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

40 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Freer HallRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Full-fat dairy

Non-fat diary

Non-dairy control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
May 8, 2023
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT04216004
Brief Title
Anti-Inflammatory Milk Matrix
Acronym
AIMM
Official Title
Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Skeletal Muscle, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full-fat dairy
Arm Type
Experimental
Arm Description
3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
Arm Title
Non-fat diary
Arm Type
Active Comparator
Arm Description
3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk.
Arm Title
Non-dairy control
Arm Type
Placebo Comparator
Arm Description
3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk.
Intervention Type
Behavioral
Intervention Name(s)
Controlled-Feeding Intervention
Intervention Description
All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Non-dairy beverage
Intervention Description
Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.
Intervention Type
Other
Intervention Name(s)
Full-fat milk
Intervention Description
3 daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
Intervention Type
Other
Intervention Name(s)
Fat-free milk
Intervention Description
3 daily servings (cup-eq) of fat-free (0%) commercial cow's milk.
Primary Outcome Measure Information:
Title
Fractional synthetic rate of myofibrillar proteins by stable isotope infusion.
Description
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.
Time Frame
0-5 hours postprandial observation period to ingesting 2 servings of respective Arm.
Title
Blood inflammation markers by flow cytometry.
Description
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.
Time Frame
1 week observation period to respective Arm within a controlled-feeding intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas A Burd, Ph.D.
Phone
217-244-0970
Email
naburd@illinois.edu
Facility Information:
Facility Name
Freer Hall
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas A Burd, Ph.D.
Phone
217-244-0970
Email
naburd@illinois.edu

12. IPD Sharing Statement

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Anti-Inflammatory Milk Matrix

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