Recruiting

Lean Beef

Sponsor:

South Dakota State University

Code:

NCT07623785

Conditions

Healthy Aging

Brain Health

Cardiometabolic Health

Normal Aging

Cognitive Decline Prevention in Robust Older Adults

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Lean Beef

Non-Beef Control

Study Details

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

Study ID

NCT07623785

Start date

Jun 3, 2026

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Lean Beef Intervention

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.

active comparator: Non-Beef Control

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.

Interventions

Lean Beef

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

Non-Beef Control

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.

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Samitinjaya Dhakal, PhD

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

Locations

South Dakota State University

Recruiting

Brookings, South Dakota, United States, 57007

Contacts

Samitinjaya Dhakal

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

More Information

Sponsor

South Dakota State University

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

  • lean beef
  • red meat
  • dietary intervention
  • brain biomarkers
  • p-tau217
  • amyloid beta
  • bdnf
  • lipidomics
  • older adults
  • neuroprotection
  • nutrition
  • metabolomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by South Dakota State University on 2026-06-03.