Healthy AgingNCT07623785
Assessing the Influence of Habitual Beef Intake on Key Molecular Markers of Brain Health
A study testing Lean Beef in people with Healthy Aging and Brain Health, run by South Dakota State University at 1 site in United States.
Trial summary
his study investigates whether eating lean beef every day can help support brain health and healthy aging in older adults. As people age, protecting memory and cognitive function becomes increasingly important. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Brain Health, Cardiometabolic Health
- What is being tested?
- Lean Beef
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 65 years and older.
- Generally healthy with no acute illnesses.
- Fluent in English.
- Willing to consume lean beef and dairy products (cottage cheese and whey protein) daily during the intervention phases.
- Willing to maintain current, habitual diet, physical activity levels, and body weight throughout the study.
- Willing to fast for 12 hours prior to clinical visits and provide blood, urine, stool, and saliva samples.
Who cannot join
- Diagnosed with Alzheimer's disease, Parkinson's disease, or other severe cognitive disorders.
- History of gastrointestinal diseases (e.g., Crohn's disease, celiac disease) or major gastrointestinal surgery.
- Uncontrolled diabetes, severe liver or kidney disease, or a recent cardiovascular event (within the past 6 months).
- Allergies or severe intolerances to beef or dairy, or adherence to a strict vegetarian or vegan diet.
- Body weight fluctuation of >5% within the past 3 months.
- Use of systemic antibiotics within the 2 months prior to baseline.
- Current heavy smoking or excessive alcohol consumption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
South Dakota State University
Brookings, South Dakota, 57007
Samitinjaya Dhakal, 605-688-5465, samitinjaya.dhakal@sdstate.edu
About this study
his study investigates whether eating lean beef every day can help support brain health and healthy aging in older adults. As people age, protecting memory and cognitive function becomes increasingly important. Lean beef is a rich source of essential nutrients-such as vitamin B12, iron, zinc, and creatine-that are known to support brain function. However, the direct biological effects of a beef-rich diet on brain health markers are not fully understood.
In this study, researchers will recruit 20 generally healthy older adults (aged 65 and older) to participate in a dietary feeding trial. Participants will complete two separate 2-week dietary phases. During one phase, participants will consume 5.5 ounces (156 grams) of provided lean beef daily. During the other phase, they will consume an iso-caloric, protein-matched, non-beef control food daily. A two-week "washout" period, where participants return to their normal diets, will separate the two phases to ensure there are no overlapping effects.
Researchers will collect blood, urine, stool, and saliva samples at the beginning and end of each 2-week dietary phase. These samples will be analyzed to see if the lean beef diet improves specific biological markers in the blood related to memory, nerve protection, and overall brain aging. Ultimately, the findings from this study will help determine if incorporating lean beef into a regular diet can be a natural, food-based strategy to help preserve neurological health in older adults.
Read the detailed description
Background and Rationale:
Cognitive decline and related dementias represent a growing public health crisis. While age and genetics are immutable risks, diet is a key modifiable factor for prevention and resilience. Lean beef provides a unique nutrient matrix-including vitamin B12, heme iron, zinc, selenium, creatine, and choline-that may support multiple aspects of brain structure and function. Recent advances in blood-based biomarkers now allow for the sensitive detection of neuropathological processes and neuroplasticity in response to lifestyle interventions. This project seeks to move beyond observational data to uncover the biological mechanisms that confer brain health by assessing the direct molecular impact of a dietary beef intervention.
Study Objectives:
The overarching goal of this study is to determine the impact of regular lean beef consumption on the molecular profile of brain health in healthy older adults. The primary aim is to quantify the within-person change in plasma phosphorylated tau-217 (p-tau217) following a 2-week lean beef intervention compared to a matched non-beef control. Secondary and exploratory aims include measuring within-person changes in the amyloid-beta 42/40 ratio (Aβ42/40) and Brain-Derived Neurotrophic Factor (BDNF), characterizing global shifts in the plasma lipidome, and exploring mechanisms of action via nutrient biomarkers.
Study Design:
The study is designed as a two-arm, randomized, controlled, crossover feeding trial. Twenty generally healthy adults (aged 65 years and older) will be block-randomized (1:1) to begin with either the intervention phase or the control phase.
Intervention Phase: Daily incorporation of 156 grams (5.5 oz) of lean beef for 14 days.
Control Phase: Daily incorporation of an iso-caloric, protein-matched non-beef control for 14 days.
A two-week washout period will separate the two phases to eliminate physiological carryover effects. Assignment of sequence will be randomized and counterbalanced to control for order and seasonal bias. Participants will maintain habitual eating patterns but will replace their daily protein sources with the study-provided food.
Methodology and Data Collection:
Clinical data and biological specimens will be collected at four distinct time points: the baseline and the conclusion of each 14-day dietary phase. At each clinical visit, fasted (12-hour) blood samples, as well as urine, stool, and saliva samples, will be collected. Basic anthropometric measurements, vital signs, and daily dietary records will also be obtained to monitor adherence and physical stability.
Outcome Evaluation and Analysis:
Targeted biomarkers of neurodegeneration and neuroplasticity (p-tau217, Aβ42/40, and BDNF) will be quantified using validated enzyme-linked immunosorbent assays (ELISA). Comprehensive untargeted lipidomic profiling will be conducted via Liquid Chromatography-Mass Spectrometry (LC-MS) workflows to identify lipid signatures associated with the intervention. Primary statistical analyses will utilize linear mixed-effects models to compare within-subject differences between the beef intervention and control conditions, adjusting for sequence and period effects. Appropriate statistical corrections will be applied for multiple comparisons and high-dimensional omics data.
- Conditions
- Healthy Aging, Brain Health, Cardiometabolic Health, Normal Aging, Cognitive Decline Prevention in Robust Older Adults
- Being tested
- Lean Beef, Non-Beef Control
- Keywords
- lean beef, red meat, dietary intervention, brain biomarkers, p-tau217, amyloid beta, bdnf, lipidomics, older adults, neuroprotection, nutrition, metabolomics
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lean BeefOther
Participants will be provided with and instructed to consume 156 grams (5.5 ounces) of cooked lean beef daily for 14 days.
Non-Beef ControlOther
Participants will be provided with and instructed to consume an iso-caloric, macronutrient- and protein-matched non-beef control consisting of a mixture of cottage cheese and whey protein daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Lean Beef Intervention | Experimental | Participants will consume 156 grams (5.5 ounces) of provided lean beef daily for a 14-day period. Participants will be instructed to maintain their habitual dietary patterns otherwise, but will replace a portion of their standard daily protein intake with the study-provided lean beef. Receives: Other: Lean Beef |
| Non-Beef Control | Active comparator | Participants will consume a provided iso-caloric, protein-matched, non-beef control food daily for a 14-day period. Participants will be instructed to maintain their habitual dietary patterns otherwise, but will replace a portion of their standard daily protein intake with the study-provided control food. Receives: Other: Non-Beef Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Phosphorylated Tau-217 (p-tau217) Concentration
Quantitative change in fasting plasma concentrations of p-tau217, a blood-based biomarker indicative of neurodegeneration and cognitive decline. This will be measured using commercially available Enzyme-Linked Immunosorbent Assays
Measured: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Change in Plasma Amyloid-Beta 42/40 (Aβ42/40) Ratio
Quantitative change in the ratio of fasting plasma Aβ42 to Aβ40, a recognized biomarker for early amyloid pathology. This will be measured using commercially available ELISA kits.
Measured: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Secondary outcomes (2)
Shift in Plasma Lipidome Profile
Global shifts in fasting plasma lipid species assessed via comprehensive untargeted lipidomics. Analysis will be conducted using Liquid Chromatography-Mass Spectrometry (LC-MS) workflows to evaluate relative abundance changes in lipid metabolites between the beef and control diets.
Measured: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Change in Gut Microbiome Composition
Alterations in gut microbial diversity and taxonomic relative abundance. This will be assessed via high-throughput sequencing (e.g., 16S rRNA or metagenomics) of DNA extracted from stool samples collected before and after each dietary phase.
Measured: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start3 Jun 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 2-period, 2-treatment randomized crossover feeding trial. Participants will be randomly assigned to one of two dietary sequences: Lean Beef followed by Control, or Control followed by Lean Beef. Each dietary intervention phase lasts 14 days, separated by a 14-day washout period where participants return to their habitual diets to prevent carryover effects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samitinjaya Dhakal, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623785
- Sponsor's protocol ID
- IRB-2026-101
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the peer-reviewed published article will be made available to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Influence of Habitual Beef Intake on Key Molecular Markers of Brain Health
- ClinicalTrials.gov ID
- NCT07623785
- Acronym / sponsor ID
- IRB-2026-101
- Conditions
- Healthy Aging, Brain Health, Cardiometabolic Health, Normal Aging, Cognitive Decline Prevention in Robust Older Adults
- Keywords
- lean beef, red meat, dietary intervention, brain biomarkers, p-tau217, amyloid beta, bdnf, lipidomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Jun 2026 (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.
his study investigates whether eating lean beef every day can help support brain health and healthy aging in older adults. As people age, protecting memory and cognitive function becomes increasingly important. Lean beef is a rich source of essential nutrients-such as vitamin B12, iron, zinc, and creatine-that are known to support brain function. However, the direct biological effects of a beef-rich diet on brain health markers are not fully understood.
In this study, researchers will recruit 20 generally healthy older adults (aged 65 and older) to participate in a dietary feeding trial. Participants will complete two separate 2-week dietary phases. During one phase, participants will consume 5.5 ounces (156 grams) of provided lean beef daily. During the other phase, they will consume an iso-caloric, protein-matched, non-beef control food daily. A two-week "washout" period, where participants return to their normal diets, will separate the two phases to ensure there are no overlapping effects.
Researchers will collect blood, urine, stool, and saliva samples at the beginning and end of each 2-week dietary phase. These samples will be analyzed to see if the lean beef diet improves specific biological markers in the blood related to memory, nerve protection, and overall brain aging. Ultimately, the findings from this study will help determine if incorporating lean beef into a regular diet can be a natural, food-based strategy to help preserve neurological health in older adults.
Detailed description
Background and Rationale:
Cognitive decline and related dementias represent a growing public health crisis. While age and genetics are immutable risks, diet is a key modifiable factor for prevention and resilience. Lean beef provides a unique nutrient matrix-including vitamin B12, heme iron, zinc, selenium, creatine, and choline-that may support multiple aspects of brain structure and function. Recent advances in blood-based biomarkers now allow for the sensitive detection of neuropathological processes and neuroplasticity in response to lifestyle interventions. This project seeks to move beyond observational data to uncover the biological mechanisms that confer brain health by assessing the direct molecular impact of a dietary beef intervention.
Study Objectives:
The overarching goal of this study is to determine the impact of regular lean beef consumption on the molecular profile of brain health in healthy older adults. The primary aim is to quantify the within-person change in plasma phosphorylated tau-217 (p-tau217) following a 2-week lean beef intervention compared to a matched non-beef control. Secondary and exploratory aims include measuring within-person changes in the amyloid-beta 42/40 ratio (Aβ42/40) and Brain-Derived Neurotrophic Factor (BDNF), characterizing global shifts in the plasma lipidome, and exploring mechanisms of action via nutrient biomarkers.
Study Design:
The study is designed as a two-arm, randomized, controlled, crossover feeding trial. Twenty generally healthy adults (aged 65 years and older) will be block-randomized (1:1) to begin with either the intervention phase or the control phase.
Intervention Phase: Daily incorporation of 156 grams (5.5 oz) of lean beef for 14 days.
Control Phase: Daily incorporation of an iso-caloric, protein-matched non-beef control for 14 days.
A two-week washout period will separate the two phases to eliminate physiological carryover effects. Assignment of sequence will be randomized and counterbalanced to control for order and seasonal bias. Participants will maintain habitual eating patterns but will replace their daily protein sources with the study-provided food.
Methodology and Data Collection:
Clinical data and biological specimens will be collected at four distinct time points: the baseline and the conclusion of each 14-day dietary phase. At each clinical visit, fasted (12-hour) blood samples, as well as urine, stool, and saliva samples, will be collected. Basic anthropometric measurements, vital signs, and daily dietary records will also be obtained to monitor adherence and physical stability.
Outcome Evaluation and Analysis:
Targeted biomarkers of neurodegeneration and neuroplasticity (p-tau217, Aβ42/40, and BDNF) will be quantified using validated enzyme-linked immunosorbent assays (ELISA). Comprehensive untargeted lipidomic profiling will be conducted via Liquid Chromatography-Mass Spectrometry (LC-MS) workflows to identify lipid signatures associated with the intervention. Primary statistical analyses will utilize linear mixed-effects models to compare within-subject differences between the beef intervention and control conditions, adjusting for sequence and period effects. Appropriate statistical corrections will be applied for multiple comparisons and high-dimensional omics data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 2-period, 2-treatment randomized crossover feeding trial. Participants will be randomly assigned to one of two dietary sequences: Lean Beef followed by Control, or Control followed by Lean Beef. Each dietary intervention phase lasts 14 days, separated by a 14-day washout period where participants return to their habitual diets to prevent carryover effects.
| Arm | Type | Receives |
|---|---|---|
| Lean Beef Intervention | Experimental | Other: Lean BeefParticipants will consume 156 grams (5.5 ounces) of provided lean beef daily for a 14-day period. Participants will be instructed to maintain their habitual dietary patterns otherwise, but will replace a portion of their standard daily protein intake with the study-provided lean beef. |
| Non-Beef Control | Active comparator | Other: Non-Beef ControlParticipants will consume a provided iso-caloric, protein-matched, non-beef control food daily for a 14-day period. Participants will be instructed to maintain their habitual dietary patterns otherwise, but will replace a portion of their standard daily protein intake with the study-provided control food. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Adults aged 65 years and older.
- Generally healthy with no acute illnesses.
- Fluent in English.
- Willing to consume lean beef and dairy products (cottage cheese and whey protein) daily during the intervention phases.
- Willing to maintain current, habitual diet, physical activity levels, and body weight throughout the study.
Key exclusion criteria (7 listed)
- Diagnosed with Alzheimer's disease, Parkinson's disease, or other severe cognitive disorders.
- History of gastrointestinal diseases (e.g., Crohn's disease, celiac disease) or major gastrointestinal surgery.
- Uncontrolled diabetes, severe liver or kidney disease, or a recent cardiovascular event (within the past 6 months).
- Allergies or severe intolerances to beef or dairy, or adherence to a strict vegetarian or vegan diet.
- Body weight fluctuation of >5% within 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 |
|---|---|---|
| Lean BeefParticipants will be provided with and instructed to consume 156 grams (5.5 ounces) of cooked lean beef daily for 14 days. | Other | Lean Beef Intervention |
| Non-Beef ControlParticipants will be provided with and instructed to consume an iso-caloric, macronutrient- and protein-matched non-beef control consisting of a mixture of cottage cheese and whey protein daily for 14 days. | Other | Non-Beef Control |
Primary outcome
Change in Plasma Phosphorylated Tau-217 (p-tau217) Concentration
Time frame: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Quantitative change in fasting plasma concentrations of p-tau217, a blood-based biomarker indicative of neurodegeneration and cognitive decline. This will be measured using commercially available Enzyme-Linked Immunosorbent Assays
Change in Plasma Amyloid-Beta 42/40 (Aβ42/40) Ratio
Time frame: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Quantitative change in the ratio of fasting plasma Aβ42 to Aβ40, a recognized biomarker for early amyloid pathology. This will be measured using commercially available ELISA kits.
2 secondary outcomes
Shift in Plasma Lipidome Profile
Time frame: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Change in Gut Microbiome Composition
Time frame: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the peer-reviewed published article will be made available to qualified researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lean Beef in people with Healthy Aging and Brain Health, 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samitinjaya Dhakal, PhD (605-688-5465, samitinjaya.dhakal@sdstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Phosphorylated Tau-217 (p-tau217) Concentration (time frame: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.). 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?
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 3 Jun 2026.