Meal Intake for Atherosclerosis

(HPL Trial)

Not currently recruiting at 2 trial locations

Overseen By Babak Razani

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Rapamycin, Torisel, Afinitor, statins

Disqualifiers: Pregnancy, Allergies, Diabetes, Heart disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how varying protein levels in meals affect heart health, focusing on specific immune cells in the blood. Participants will receive one of three liquid meals: a standard protein meal, a high protein meal, or a low protein meal with added leucine, a nutrient that can influence cell activity. The researchers aim to observe how these meals alter blood cell behavior, potentially relating to heart disease risk. Individuals without a history of heart disease, diabetes, high blood pressure, or certain other conditions, and who can consume milk-based meals, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to advance scientific understanding of nutrition and heart health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. If you are taking Rapamycin, Torisel, Afinitor, or any statin medication, you cannot participate in the trial.

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

Research has shown that high protein diets can have mixed effects on heart health. Some studies have found no link between high protein intake and increased risks of stroke or heart-related deaths. However, other research suggests that consuming a lot of protein might raise the risk of heart attacks or strokes. On the positive side, high protein diets are often associated with effective weight management, which benefits overall health.

For the low protein meal with added leucine, studies in humans remain less clear, but some research in mice suggests that leucine might improve metabolism and lower heart disease risks. Leucine, an amino acid, can influence how cells manage energy.

In summary, while concerns exist about high protein diets and heart health, the evidence is mixed. Adding leucine might offer some benefits, but most data comes from animal studies. Consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for atherosclerosis, which often involve medications like statins to lower cholesterol, this trial is exploring the impact of meal composition on the condition. Researchers are excited about these treatments because they focus on dietary modifications that might offer a non-pharmaceutical approach to managing atherosclerosis. The trial involves different meal compositions: a standard protein meal, a high protein meal, and a low protein meal enhanced with leucine. This approach is unique because it examines how varying protein levels and the addition of leucine could influence heart health, potentially offering a new dietary strategy to combat atherosclerosis.

What evidence suggests that this trial's meals could be effective for atherosclerosis?

This trial will compare the effects of different meal compositions on heart health. Participants will receive one of the following: a standard protein meal, a high protein meal, or a low protein meal with added leucine. Research has shown that high protein diets have mixed effects on heart health. Some studies suggest they might lower blood pressure and aid in weight management. However, other research indicates that high protein diets could increase the risk of heart disease by causing plaque build-up in arteries. Conversely, adding leucine, a type of protein, to a low protein diet has shown promising results in mice, reducing artery plaque and improving cholesterol levels. These findings highlight the complex role of protein and leucine in heart health, and more research is needed to fully understand their effects in humans. ^{2 4 5 6 7}

Who Is on the Research Team?

Bettina Mittendorfer

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for adults who can consume milk-based liquid meals. It's not suitable for those with a history of organ transplant, diabetes, heart disease, high blood pressure, stroke or cancer. Pregnant individuals and those allergic to meal ingredients or on certain medications like Rapamycin/Sirolimus and statins cannot participate.

Inclusion Criteria

Can drink a meal made with milk.

Exclusion Criteria

I have had cancer in the past.

I have had a stroke in the past.

You are allergic to any of the ingredients in the meal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. Blood is collected before and after meal ingestion to evaluate mTOR signaling.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Meal

Trial Overview The study tests the effects of different protein levels in meals on cardiovascular risk factors. Participants will receive one of three types of liquid meals: low protein, high protein, or low protein with added leucine (which activates mTOR signaling). Blood samples will be taken before and after meal consumption to analyze monocyte and platelet activation.

How Is the Trial Designed?

Group I: Standard protein meal Active Control 1 Intervention

Participants will receive a standard protein meal, containing about 10% of energy as protein

Group II: High protein meal Active Control 1 Intervention

Participants will receive a high protein meal, containing about 50% of energy as protein

Group III: Low protein meal + leucine Active Control 1 Intervention

Participants will receive a standard protein meal, containing about 10% of energy as protein to which leucine has been added to match the total leucine content of the high protein meal

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A diet plays a crucial role in preventing atherosclerosis, a condition characterized by the buildup of fats and cholesterol in arteries.

New functional meat foods have been developed that contain significantly lower cholesterol levels compared to traditional meat, making them a promising option for atherosclerosis prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Functional meat food in atherosclerosis prevention]. Chernobel'skiĭ, GN., Davletbaev, RM., Sazonova, EN., et al.[2006]

Home-delivered meal services, like Meals on Wheels, can enhance energy and protein intake for older adults by including protein-enriched options and providing full-day meal plans, according to a systematic review of 19 studies.

Despite the positive outcomes, none of the studies were rated as high quality, highlighting the need for further research to optimize these meal services for better nutritional care at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. IJmker-Hemink, VE., Dijxhoorn, DN., Briseno Ozumbilla, CM., et al.[2020]

In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting over 75% of their energy requirements, compared to 76% in the historical intervention group.

The intervention group also showed a significant increase in mean energy and protein intake, with 31 kcal/kg and 1.2 g protein/kg, respectively, indicating that this combined approach is more effective than using a protein-enriched menu alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. Munk, T., Bruun, N., Nielsen, MA., et al.[2018]

A home delivery meal service providing energy-dense, protein-rich meals significantly improved quality of life and lower body strength in 40 malnourished lung cancer patients over 12 weeks.

Patients receiving the meal service showed better performance scores and increased hand grip strength, indicating that enhanced nutrition can positively impact functional status in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Home Delivery Meal Service of Energy- and Protein-Rich Meals on Quality of Life in Malnourished Outpatients Suffering from Lung Cancer: A Randomized Controlled Trial. Leedo, E., Gade, J., Granov, S., et al.[2018]

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10058321/

The Impact of High Protein Diets on Cardiovascular ... In conclusion, according to our study results, high protein consumption does not affect cardiovascular prognosis. Keywords: high protein intake, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7053091/

High-protein diets increase cardiovascular risk by ... We show that dietary protein drives atherosclerosis and lesion complexity. Protein ingestion acutely elevates amino acid levels in blood and atherosclerotic ...

3. withpower.com withpower.com/trial/phase-atherosclerosis-4-2022-6e939

High Protein Diet for Atherosclerosis (HPA Trial) Some studies suggest that high protein diets, especially from plant sources, may reduce blood pressure and prevent cardiovascular disease. However, long-term ...

4. atherosclerosis-journal.com atherosclerosis-journal.com/article/S0021-9150(19)30901-3/fulltext

Acute Effects Of A High-Protein Diet On Cardiovascular ... Conclusions: Acutely, HP was associated with a lower increase in serum triglyceride concentrations, potentially yielding cardiometabolic ...

5. academic.oup.com academic.oup.com/nutritionreviews/article/83/3/e814/7715016

Impact of Quantity and Type of Dietary Protein on ... Higher protein diets (HPDs) have shown favorable outcomes on weight maintenance and body-composition management; however, their protective ...

6. sciencemediacentre.org sciencemediacentre.org/expert-reaction-to-study-looking-at-high-protein-intakes-and-atherosclerosis-some-data-in-mice-and-some-in-people/

expert reaction to study looking at high protein intakes and ... This research provides evidence that a high-protein diet might trigger responses in the body that contribute to the risk of heart attack or stroke.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523295404

Protein, body weight, and cardiovascular health Epidemiologic studies have linked high-protein intake with lower risk of hypertension and CHD. In addition, very low levels of animal protein intake have been ...