Healthy LifestyleNCT06261775
Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline
A study testing Red meat-based meal and No meat diet in people with Healthy Lifestyle, run by South Dakota State University at 1 site in United States.
Trial summary
Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Red meat-based meal and No meat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 2 Jul 2026
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Generally, good health status based on one routine physical in the past 15 months, current health status
- Normal HbA1C, weigh 110 lb or more
- Age 65 years or more, generally healthy, all races and both sexes
- Generally practicing a meat-based dietary pattern, do not have any special dietary requirements, and
- Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
Who cannot join
- Medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
- Not on any special diet within 3 months of recruitment, and do not intend to lose weight
- Impaired kidney functions
- Active history of cancer, diabetes, heart, liver, and kidney diseases
- Major gastrointestinal disorders in the past 3 months
- History of heart attacks or stroke
Show all 10Show fewer
- Unable to meet in-person visit requirements for dining, picking up meals, and tests
- Any mental health condition affecting the ability to provide written informed consent
- If they had not had a routine health checkup 12 months before recruitment.
- If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverages during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University, Wagner Hall 416
Brookings, South Dakota, 57007
About this study
Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a healthy diet following macronutrient recommendations for Americans will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same.
- Conditions
- Healthy Lifestyle
- Being tested
- Red meat-based meal, No meat diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red meat-based mealOther
Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.
No meat dietOther
Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Low UPF no meat Receives: Other: Red meat-based meal; Other: No meat diet |
| Test | Experimental | Low UPF with Red meat Receives: Other: Red meat-based meal; Other: No meat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of phosphatidylcholine in blood
Using Microplate Assay
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start30 Jan 2024
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moul Dey, South Dakota State University
- Investigators
- Moul Dey, Ph.D, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261775
- Sponsor's protocol ID
- IRB-2401011-EXM
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vaezi S, de Vargas BO, Weidauer L, Freeling JL, Dey M. Effects of Minimally Processed Red Meat within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. Curr Dev Nutr. 2025 Dec 10;10(1):107615. doi: 10.1016/j.cdnut.2025.107615. eCollection 2026 Jan.
PubMed 41551721Vaezi S, de Vargas BO, Freeling JL, Weidauer L, Dey M. Effects of Minimally Processed Red Meat Within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333443. doi: 10.1101/2025.08.11.25333443.
PubMed 40832369
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline
- ClinicalTrials.gov ID
- NCT06261775
- Acronym / sponsor ID
- IRB-2401011-EXM
- Conditions
- Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 15 Feb 2024 (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.
Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a healthy diet following macronutrient recommendations for Americans will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Red meat-based meal, Other: No meat dietLow UPF no meat |
| Test | Experimental | Other: Red meat-based meal, Other: No meat dietLow UPF with Red meat |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Generally, good health status based on one routine physical in the past 15 months, current health status
- Normal HbA1C, weigh 110 lb or more
- Age 65 years or more, generally healthy, all races and both sexes
- Generally practicing a meat-based dietary pattern, do not have any special dietary requirements, and
- Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
Key exclusion criteria (10 listed)
- Medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
- Not on any special diet within 3 months of recruitment, and do not intend to lose weight
- Impaired kidney functions
- Active history of cancer, diabetes, heart, liver, and kidney diseases
- Major gastrointestinal disorders in the past 3 months
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 |
|---|---|---|
| Red meat-based mealParticipants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention. | Other | Control, Test |
| No meat dietParticipants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention. | Other | Control, Test |
Primary outcome
Concentration of phosphatidylcholine in blood
Time frame: 8 weeks
Using Microplate Assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 41551721Vaezi S, de Vargas BO, Weidauer L, Freeling JL, Dey M. Effects of Minimally Processed Red Meat within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. Curr Dev Nutr. 2025 Dec 10;10(1):107615. doi: 10.1016/j.cdnut.2025.107615. eCollection 2026 Jan.
- Derived from this study: PubMed 40832369Vaezi S, de Vargas BO, Freeling JL, Weidauer L, Dey M. Effects of Minimally Processed Red Meat Within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333443. doi: 10.1101/2025.08.11.25333443.
Related trials for Healthy Lifestyle
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Major Depressive Disorder (MDD)
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.
Moul Dey, Ph.D principal investigator
South Dakota State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red meat-based meal and No meat diet in people with Healthy Lifestyle, run by South Dakota State University 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 10 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: finished, as of the sponsor's last update on 17 Sep 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of phosphatidylcholine in blood (time frame: 8 weeks). 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 NCT06261775, which also lists 2 linked publications.
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 17 Sep 2026.