ObesityAIMMNCT04216004
Anti-Inflammatory Milk Matrix
A study testing Non-dairy beverage, Full-fat milk and Fat-free milk in people with Obesity and Skeletal Muscle, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Skeletal Muscle, Inflammation
- What is being tested?
- Non-dairy beverage, Full-fat milk and Fat-free milk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2020to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Freer Hall
Urbana, Illinois, 61801
Nicholas A Burd, Ph.D., 217-244-0970, naburd@illinois.edu
About this study
Official title: Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis
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.
- Conditions
- Obesity, Skeletal Muscle, Inflammation
- Being tested
- Controlled-Feeding Intervention, Non-dairy beverage, Full-fat milk, Fat-free milk
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled-Feeding InterventionBehavioural
All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.
Non-dairy beverageDietary supplement
Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.
Full-fat milkOther
3 daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
Fat-free milkOther
3 daily servings (cup-eq) of fat-free (0%) commercial cow's milk.
| Study group | Role | What they receive |
|---|---|---|
| Full-fat dairy | Experimental | 3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk. Receives: Behavioral: Controlled-Feeding Intervention; Other: Full-fat milk |
| Non-fat diary | Active comparator | 3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk. Receives: Behavioral: Controlled-Feeding Intervention; Other: Fat-free milk |
| Non-dairy control | Placebo comparator | 3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk. Receives: Behavioral: Controlled-Feeding Intervention; Dietary Supplement: Non-dairy beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-5 hours postprandial observation period to ingesting 2 servings of respective Arm.
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.
Measured: 1 week observation period to respective Arm within a controlled-feeding intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start14 Feb 2020
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Burd, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216004
- Sponsor's protocol ID
- 20173
- Acronym
- AIMM
- Status last verified
- May 2023
- First submitted
- 5 Dec 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barnes TM, Zupancic Z, Deutz MT, Askow AT, McKenna CF, Aguilera JA, Tinline-Goodfellow CT, Ulanov AV, Willard JW, West DWD, De Lisio M, Moore DR, Burd NA. Full-fat dairy milk vs. isolated free nutrient blend on postprandial protein metabolism and inflammatory markers in adults with overweight and obesity. Clin Nutr ESPEN. 2026 Aug;74:103358. doi: 10.1016/j.clnesp.2026.103358. Epub 2026 May 26.
PubMed 42203109
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis
- ClinicalTrials.gov ID
- NCT04216004
- Acronym / sponsor ID
- AIMM / 20173
- Conditions
- Obesity, Skeletal Muscle, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-fat dairy | Experimental | Behavioral: Controlled-Feeding Intervention, Other: Full-fat milk3x daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk. |
| Non-fat diary | Active comparator | Behavioral: Controlled-Feeding Intervention, Other: Fat-free milk3x daily servings (cup-eq) of non-fat (0%) commercial cow's milk. |
| Non-dairy control | Placebo comparator | Behavioral: Controlled-Feeding Intervention, Dietary Supplement: Non-dairy beverage3x daily servings (cup-eq) of non-dairy sourced macronutrient composition of full-fat milk. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled-Feeding InterventionAll energy-containing food and beverages will be provided for 1-week as a controlled-feeding study. | Behavioural | Full-fat dairy, Non-dairy control, Non-fat diary |
| Non-dairy beverageIsolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk. | Dietary supplement | Non-dairy control |
| Full-fat milk3 daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk. | Other | Full-fat dairy |
| Fat-free milk3 daily servings (cup-eq) of fat-free (0%) commercial cow's milk. | Other | Non-fat diary |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 42203109Barnes TM, Zupancic Z, Deutz MT, Askow AT, McKenna CF, Aguilera JA, Tinline-Goodfellow CT, Ulanov AV, Willard JW, West DWD, De Lisio M, Moore DR, Burd NA. Full-fat dairy milk vs. isolated free nutrient blend on postprandial protein metabolism and inflammatory markers in adults with overweight and obesity. Clin Nutr ESPEN. 2026 Aug;74:103358. doi: 10.1016/j.clnesp.2026.103358. Epub 2026 May 26.
Related trials for Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-dairy beverage, Full-fat milk and Fat-free milk in people with Obesity and Skeletal Muscle, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas A Burd, Ph.D. (217-244-0970, naburd@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.