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Anti-Inflammatory Milk Matrix (AIMM)

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ClinicalTrials.gov Identifier: NCT04216004
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Nicholas Burd, University of Illinois at Urbana-Champaign

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.

Condition or disease Intervention/treatment Phase
Obesity Skeletal Muscle Inflammation Dietary Supplement: Diet-controlled intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: Full-fat dairy
3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
Dietary Supplement: Diet-controlled intervention
1-week weight-maintenance diet-controlled intervention.

Active Comparator: Non-fat diary
3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk.
Dietary Supplement: Diet-controlled intervention
1-week weight-maintenance diet-controlled intervention.

Placebo Comparator: Non-dairy control
3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk.
Dietary Supplement: Diet-controlled intervention
1-week weight-maintenance diet-controlled intervention.




Primary Outcome Measures :
  1. Compare fractional synthesis rate of myofibrillar protein to different dairy matrices [ Time Frame: 0-5 hours postprandial observation period to ingesting 2 servings of respective Arm ]
    Rate of building new proteins in skeletal muscle contractile protein fraction after a meal

  2. Compare concentration of inflammation markers in the blood to different dairy matrices [ Time Frame: 1 week observation period to respective Arm within a weight-maintenance diet ]
    Measurement of blood cytokines, monocytes, and macrophages before and after a diet intervention.



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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Nicholas Burd, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04216004    
Other Study ID Numbers: 20173
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes