Assessing the Influence of Habitual Beef Intake on Key Molecular Markers of Brain Health

NCT07623785 | Recruiting

• 1 other identifier: IRB-2026-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; older adults; neuroprotection; nutrition; metabolomics

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.

Secondary Outcomes (2)

• Shift in Plasma Lipidome Profile

  Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.

• Change in Gut Microbiome Composition

  Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.

Study Arms (2)

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.

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.

Other: Non-Beef Control

Interventions

Lean Beef OTHER

Participants will be provided with and instructed to consume 156 grams (5.5 ounces) of cooked lean beef daily for 14 days.

Lean Beef Intervention

Non-Beef Control OTHER

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.

Non-Beef Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead

Study Sites (1)

South Dakota State University

Brookings, South Dakota, 57007, United States

RECRUITING

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samitinjaya Dhakal, PhD

CONTACT

605-688-5465; samitinjaya.dhakal@sdstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the use of whole-food dietary interventions (lean beef vs. non-beef control), it is not possible to blind the participants or the investigators administering the diets. However, all biological specimens (blood, urine, stool, saliva) will be de-identified and coded. The outcomes assessors (laboratory personnel conducting the targeted biomarker assays and untargeted lipidomics) will remain blinded to the intervention sequence and treatment assignments during analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available immediately following the publication of the primary manuscript and will remain accessible for 5 years.
• Access Criteria: Data will be shared with qualified academic researchers who submit a methodologically sound proposal that has been approved by an independent review committee identified for this purpose. Proposals must be directed to the Principal Investigator. Data will only be shared for the purpose of achieving the aims explicitly outlined in the approved proposal, and a data-sharing agreement must be signed.

Locations

US (1)