Anti-Inflammatory Milk Matrix

NCT ID: NCT04216004

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Skeletal Muscle Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Full-fat dairy

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

Group Type EXPERIMENTAL

Controlled-Feeding Intervention

Intervention Type BEHAVIORAL

All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.

Full-fat milk

Intervention Type OTHER

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

Non-fat diary

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

Group Type ACTIVE_COMPARATOR

Controlled-Feeding Intervention

Intervention Type BEHAVIORAL

All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.

Fat-free milk

Intervention Type OTHER

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

Non-dairy control

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

Group Type PLACEBO_COMPARATOR

Controlled-Feeding Intervention

Intervention Type BEHAVIORAL

All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.

Non-dairy beverage

Intervention Type DIETARY_SUPPLEMENT

Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.

Interventions

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Controlled-Feeding Intervention

All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.

Intervention Type BEHAVIORAL

Non-dairy beverage

Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.

Intervention Type DIETARY_SUPPLEMENT

Full-fat milk

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

Intervention Type OTHER

Fat-free milk

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Burd

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Freer Hall

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicholas A Burd, Ph.D.

Role: CONTACT

217-244-0970

Facility Contacts

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Nicholas A Burd, Ph.D.

Role: primary

217-244-0970

Other Identifiers

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20173

Identifier Type: -

Identifier Source: org_study_id

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