Beef Protein for Vascular Disease

Overseen By Andrew Hall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anticoagulants, Metformin, Statins

Disqualifiers: Diabetes, Heart disease, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if beef protein can improve heart health by enhancing zinc absorption, a mineral crucial for many body functions. It will compare a beef stew with a plant-based stew, both rich in zinc and protein, to assess which is more effective. Ideal participants are men or postmenopausal women aged 55 to 70 who do not follow special diets and maintain a stable medication routine. As an unphased trial, this study allows participants to contribute to valuable nutritional research that could enhance heart health.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of your prescribed medications for at least 6 months. However, if you are taking anticoagulants, metformin, statins, or medications that interfere with zinc, protein, or lipid metabolism, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown mixed results regarding the safety and health effects of eating beef protein, like the kind used in this trial. Some studies suggest that increased beef consumption might raise the risk of heart disease, while others have found only a weak connection between unprocessed red meat and heart disease or other health issues.

The trial is in the "Not Applicable" phase, indicating that the treatment is still under study, and specific safety information might not be fully available yet. For those who already consume beef protein, the trial might not pose significant risks, but consulting a doctor is always advisable to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for vascular disease, which often involve medications like statins or lifestyle changes such as diet and exercise, the investigational beef protein treatment offers a unique approach. This treatment is derived from beef stew, providing a specific nutritional profile of 8.8 mg of zinc and 37.9 mg of protein. Researchers are intrigued by the potential of beef protein to positively impact vascular health through its nutrient composition, which could support heart and blood vessel functions in a way that traditional medications do not. This study aims to explore whether a dietary approach using beef protein can offer benefits that are not typically achieved with current standard care options.

What evidence suggests that beef protein could be an effective treatment for vascular disease?

This trial will compare the effects of beef protein with animal protein on vascular health. Research suggests that beef might not be ideal for heart health. Some studies have shown that eating more red meat can lead to issues like higher blood pressure. One study found that red meat might lower triglycerides (a type of fat in the blood), but this benefit does not outweigh the overall risks. Another review showed that most studies found either negative or no effects on heart health from consuming unprocessed red meat. While beef might aid in zinc absorption, strong evidence does not support its benefit for heart health. ^{2 5 6 7 8}

Who Is on the Research Team?

Carl L Keen, PhD

Principal Investigator

Distinguished Professor Emeritus of Nutrition

Are You a Good Fit for This Trial?

This trial is for men and postmenopausal women aged 55-70 with a BMI of 18.5-29.9, not on daily anticoagulants or intense exercise routines, without heart disease, diabetes, cancer in the past 5 years, or malabsorption issues. Participants should be non-smokers and not on diets like Keto or Paleo.

Inclusion Criteria

Subject is willing and able to comply with the study protocols

Subject is willing to participate in all study procedures

Men or women who have gone through menopause and are between 55 and 70 years old.

Exclusion Criteria

You take daily blood thinners like aspirin or NSAIDs.

You regularly do intense exercise.

You have kidney or liver disease that you have reported yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants consume a mixed diet including beef for 4 weeks to assess zinc absorption and vascular function

4 weeks

1 visit (in-person) at the start and end of the period

Washout

Participants undergo a washout period between treatment phases

2-4 weeks

Treatment Period 2

Participants consume a mixed diet including non-meat protein sources for 4 weeks to assess zinc absorption and vascular function

4 weeks

1 visit (in-person) at the start and end of the period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Beef protein

Trial Overview The study tests if beef as part of a healthy diet can improve zinc absorption into cells to support cardiovascular health in older adults at risk of zinc deficiency and vascular diseases.

How Is the Trial Designed?

Group I: Beef Protein Experimental Treatment 1 Intervention

A beef stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);

Group II: Animal Protein Active Control 1 Intervention

A control plant protein stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cattlemen's Beef Association

Industry Sponsor

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Industry Sponsor

National Cattlemen's Beef Association

Collaborator

Trials

26

Recruited

1,300+

Published Research Related to This Trial

In a 6-week double-blind study involving 55 postmenopausal women, soy protein containing native phytate significantly reduced total homocysteine (tHcy) and iron levels, which are risk factors for cardiovascular disease.

The study suggests that incorporating phytate-rich foods and managing body weight can help lower cardiovascular disease risk factors in postmenopausal women, while isoflavones did not show any significant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of soy isoflavones and phytate on homocysteine, C-reactive protein, and iron status in postmenopausal women. Hanson, LN., Engelman, HM., Alekel, DL., et al.[2023]

In a study involving 18 male volunteers at high risk for cardiovascular disease, consuming n-3-enriched reduced fat pâtés/frankfurters significantly lowered LDL-cholesterol and markers of thrombosis and insulin resistance, suggesting a beneficial effect on cardiovascular health.

The results indicate that lipid-improved meat products, particularly those enriched with omega-3 fatty acids, could be a valuable addition to dietary strategies aimed at reducing cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coagulation, Thrombogenesis, and Insulin Resistance Markers in Increased-Cardiovascular-Risk Subjects Consuming Improved-Fat Meat Products. Celada, P., Olmedilla-Alonso, B., Delgado-Pando, G., et al.[2020]

Feeding German Holstein bulls a diet rich in 18:3n-3 (from grass silage and linseed oil) significantly increased beneficial fatty acids in the beef, with levels of 18:3n-3, EPA, and Σn-3 LC-PUFA rising by 2.6, 2.3, and 1.7 times, respectively.

The study found that the n-3 polyunsaturated fatty acids (PUFAs) from the beef were effectively transferred into processed beef products, such as German Corned Beef, without being affected by processing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary PUFA Intervention Affects Fatty Acid- and Micronutrient Profiles of Beef and Related Beef Products. Dannenberger, D., Nuernberg, K., Herdmann, A., et al.[2020]

In a study involving 23 men, adding high-fat ground beef (HFB) to their diet improved vascular function, specifically enhancing flow-mediated dilation (FMD) and lowering blood pressure without negatively affecting overall vascular health.

Both low-fat and high-fat ground beef did not harm vascular function, suggesting that red meat can be included in a diet without adverse effects, and the benefits of HFB may be linked to reductions in LDL cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Vascular Function in Response to High-Fat and Low-Fat Ground Beef Consumption in Men. Lytle, JR., Stanelle, ST., Martin, SE., et al.[2023]

Beef protein supplementation in elite male triathletes led to a significant increase in thigh cross-sectional area and a more favorable testosterone-to-cortisol ratio, suggesting enhanced anabolic effects compared to carbohydrate supplementation.

Despite these positive changes in muscle mass and hormonal balance, beef protein did not significantly affect hematological variables such as iron levels or red blood cell counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Beef Protein Supplementation in Male Elite Triathletes: A Randomized, Controlled, Double-Blind, Cross-Over Study. Valenzuela, PL., Montalvo, Z., Mata, F., et al.[2023]

Replacing dietary carbohydrates with beef protein can lead to significant reductions in plasma triglycerides and cholesterol levels, independent of the saturated fat content in the diet, based on a study involving 40 healthy men over a 3-week baseline and subsequent 3-week dietary interventions.

The study suggests that the source of dietary protein, such as beef, may influence how saturated fat affects atherogenic lipoproteins, indicating that dietary choices can play a crucial role in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in atherogenic dyslipidemia induced by carbohydrate restriction in men are dependent on dietary protein source. Mangravite, LM., Chiu, S., Wojnoonski, K., et al.[2023]

Hybrid beef from Angus cattle and wild yaks has a similar protein content to traditional Angus beef but contains significantly less fat (1.2% vs. 2.5%), making it a potentially healthier option.

The hybrid beef exhibits higher biological value, with better ratios of essential to non-essential amino acids and greater amounts of key essential amino acids, suggesting it may provide superior nutritional benefits compared to traditional beef.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study of biological value of beef produced by interspecies hybrids of domestic cattle and wild yaks]. Bagirov, VA., Chernukha, IM., Lisitsin, AV., et al.[2015]

In a study involving 18 male volunteers at increased risk for cardiovascular disease, reduced-fat (RF) and omega-3-enriched reduced-fat (n-3RF) pork products positively influenced several cardiovascular disease biomarkers, improving ratios related to antioxidant activity and reducing inflammatory markers.

Conversely, normal-fat (NF) pork products were associated with increased levels of oxidized low-density lipoproteins (oxLDL) and lipoprotein(a) (Lp(a)), suggesting that high consumption of NF products should be limited due to their potential negative impact on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of improved fat meat products consumption on emergent cardiovascular disease markers of male volunteers at cardiovascular risk. Celada, P., Sánchez-Muniz, FJ., Delgado-Pando, G., et al.[2018]

In an 8-week study involving adults, supplementation with 40g of soybean protein significantly reduced plasma levels of E-selectin and leptin, which are biomarkers associated with inflammation and cardiovascular risk.

The study suggests that soybean protein may have protective effects on certain cardiovascular disease risk factors, although further research is needed to understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of soybean protein on novel cardiovascular disease risk factors: a randomized controlled trial. Rebholz, CM., Reynolds, K., Wofford, MR., et al.[2021]

In a 16-week study involving 36 overweight or obese women, moderate weight loss (9% of body weight) significantly improved cardiovascular risk factors, including a 28% increase in systemic arterial compliance (SAC) and reductions in total and LDL cholesterol, triglycerides, and leptin levels.

Both a diet emphasizing red meat and one focusing on plant protein (soybeans) led to similar metabolic benefits, indicating that weight loss and its cardiovascular improvements can be achieved with either dietary approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial compliance, blood pressure, plasma leptin, and plasma lipids in women are improved with weight reduction equally with a meat-based diet and a plant-based diet. Yamashita, T., Sasahara, T., Pomeroy, SE., et al.[2019]

In a study of 142 older adults, increased beef intake was linked to greater muscle mass, with a 1 oz/day increase predicting a 2.3 cm² rise in mid-arm muscle area, suggesting that beef can help preserve muscle in aging individuals.

Higher overall protein intake was associated with better nutrition status and body measurements, indicating that consuming lean beef in moderation can be a beneficial way for older adults to enhance their protein intake and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary protein and beef consumption predict for markers of muscle mass and nutrition status in older adults. Asp, ML., Richardson, JR., Collene, AL., et al.[2021]

In two experiments with male turkeys, diets including cooked ground beef from both forage-finished and grain-finished cattle increased plasma triglyceride and phospholipid levels, indicating a potential impact on lipid metabolism.

Despite the increase in triglycerides and phospholipids, neither type of beef significantly raised plasma cholesterol or HDL cholesterol levels, although the grain-finished beef diet did increase apolipoprotein A-I levels, suggesting a nuanced effect on lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of feeding cooked ground beef on plasma lipid and apolipoprotein concentrations in male turkeys. Williams, JE., Kelley, JL., Wagner, DG., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39649475/

Beef Consumption and Cardiovascular Disease Risk Factors Conclusions: Daily unprocessed beef intake do not significantly affect most blood lipids, apolipoproteins, or blood pressures, except for a ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.035225

Meta-Analysis of Randomized Controlled Trials of Red ... In comparison with carbohydrates, red meat yielded greater decreases in triglycerides (WMD, –0.181 mmol/L; 95% CI, –0.349 to –0.013).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10060708/

State-of-the-Art Review: Evidence on Red Meat Consumption ... Accumulating evidence links red meat intake to a higher risk of poorly controlled blood pressure and hypertension, with a dose-dependent relationship.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0261561425002493

Effect of red meat consumption on cardiovascular risk factors A systematic review and meta-analysis indicated that higher red meat consumption is associated with poorer cardiovascular health outcomes [4].

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(25)00126-1/abstract

Industry study sponsorship and conflicts of interest on the ... All independent studies reported either unfavorable (73.3%) or neutral (26.7%) cardiovascular outcomes when consuming unprocessed red meat.

6. jn.nutrition.org jn.nutrition.org/article/S0022-3166(23)72841-1/fulltext

Red Meat Intake and the Risk of Cardiovascular Diseases Red meat consumption was associated with an increased risk of cardiovascular disease (CVD) in prospective cohort studies and a profile of ...

7. nature.com nature.com/articles/s41591-022-01968-z

Health effects associated with consumption of unprocessed ... We found weak evidence of association between unprocessed red meat consumption and colorectal cancer, breast cancer, type 2 diabetes and ischemic heart disease.

8. sciencedirect.com sciencedirect.com/science/article/pii/S247529912402434X

Beef Consumption and Cardiovascular Disease Risk Factors Specifically, higher red meat intake has been associated with adverse cardiovascular disease (CVD) outcomes including CVD mortality in the United States [3,4] ...