Meal Intake for Atherosclerosis

(HPL Trial)

Recruiting at 1 trial location

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

10 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Meal for Atherosclerosis?

Research shows that meal services providing energy- and protein-rich meals can improve dietary intake and quality of life in patients at nutritional risk, such as those with lung cancer. This suggests that similar meal-based interventions might help improve nutritional status and potentially benefit patients with atherosclerosis. ^{1 2 3 4 5}

Is the meal intake treatment generally safe for humans?

The research does not provide specific safety data for the meal intake treatment, but it does explore how meal patterns and timing can affect cardiovascular health. No direct safety concerns are mentioned in the studies. ^{6 7 8 9 10}

How does the Meal treatment for atherosclerosis differ from other treatments?

The Meal treatment for atherosclerosis is unique because it focuses on dietary changes, specifically using functional meat food with lower cholesterol levels, as a preventive measure. Unlike traditional drug treatments like statins, which lower cholesterol through medication, this approach emphasizes modifying diet to prevent the disease. ^{10 11 12 13 14}

What is the purpose of this trial?

High protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. It is controversial if these diets are associated with an increased risk of cardiovascular disease. Recent work in mice has implicated monocytes/macrophages and mTOR signaling as the culprit cell type driving the increased cardiovascular risk with high protein diets. We aim to build on this preclinical research by evaluating the effects of liquid meals with different protein and leucine (a potent mTOR activator) contents on circulating human monocytes and platelets. Study participants will be given either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. Blood will be collected from study participants just just prior to and for several hours after ingestion of the meals. Activation of amino acid-dependent signaling pathways (particularly mTOR) and downstream sequelae will be evaluated in the isolated monocytes and platelets.

Research Team

Bettina Mittendorfer

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2018]

2. United States 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. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

"Eat your lunch!" - controversies in the nutrition of the acutely, non-critically ill medical inpatient. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

Association of at-home and out-of-home eating frequency with the estimated 10-year arteriosclerotic cardiovascular disease risk in rural population: the Henan Rural Cohort Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Meal patterns in healthy adults: Inverse association of eating frequency with subclinical atherosclerosis indexes. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Moderate Postmeal Walking Has No Beneficial Effects Over Resting on Postprandial Lipemia, Glycemia, Insulinemia, and Selected Oxidative and Inflammatory Parameters in Older Adults with a Cardiovascular Disease Risk Phenotype: A Randomized Crossover Trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Supper Timing and Cardiovascular Mortality: The Japan Collaborative Cohort Study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Consumption of a high-fat breakfast on consecutive days alters preclinical biomarkers for atherosclerosis. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Current strategies for atherosclerosis and lowering cholesterol. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Diet and murine atherosclerosis. [2007]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Functional meat food in atherosclerosis prevention]. [2006]

14. France pubmed.ncbi.nlm.nih.gov

[Primary nutritional and drug prevention of atherosclerosis]. [2019]