Body Composition Effects for Vascular Health

Overseen By Bryant H Keirns, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ball State University

Must not be taking: Anti-inflammatories, Statins, Metformin, others

Disqualifiers: Cardiovascular disease, Diabetes, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how body composition, specifically the ratio of body fat to muscle, affects heart health in women with a normal BMI (body mass index, a measure of body fat based on height and weight). Participants will visit the lab twice: once to consume a high-fat meal and once to complete a stress task. Women with a normal BMI, no heart or metabolic diseases, and no dietary restrictions may be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to understanding heart health in women.

Will I have to stop taking my current medications?

If you regularly take anti-inflammatory drugs, you may need to temporarily stop using them. You cannot participate if you use lipid-lowering drugs, glucose-lowering drugs, or tobacco products.

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

Past studies have shown that eating high-fat meals changes the body's fat levels, which are important for heart health. Some research suggests that certain fats might reduce the risk of stroke and improve heart health. However, other studies indicate that high-fat diets can increase harmful substances in the body that damage cells.

Regarding stress, research results are mixed. Some studies found no direct link between stress and changes in body weight or shape, while others suggest stress might impact heart and brain health.

In this trial, participants will consume a high-fat meal and complete a stress-related task. Both have been studied for their effects on the body, and while some risks exist, they are generally safe in controlled settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how stress and high-fat meals impact vascular health and body composition. Unlike typical treatments that focus on medications or lifestyle changes to improve heart health, this trial explores the immediate physiological responses to stress and dietary intake. By focusing on these everyday factors, the findings could lead to practical, real-world strategies to enhance vascular health, potentially offering new insights beyond traditional approaches like diet plans and stress management programs.

What evidence suggests that this trial's treatments could be effective for vascular health?

This trial will compare the effects of high-fat meals and stress on vascular health. Research has shown that consuming just one high-fat meal can impair blood vessel function, with more severe effects in individuals with pre-existing blood vessel issues. Participants in the "High-fat meal trial" will eat two Jimmy Dean's breakfast bowls to assess these effects. Meanwhile, the "Stress trial" will evaluate how mental stress affects vascular health, as ongoing stress has been linked to poorer heart and blood vessel health. These findings suggest that both high-fat meals and stress can impact heart health, particularly in individuals with varying levels of body fat and muscle. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for females with a 'healthy' BMI who are interested in learning how their body composition affects vascular health. Participants should have varying levels of body fat and muscle mass but still fall within the healthy weight range according to BMI standards.

Inclusion Criteria

You are not pregnant or expecting to become pregnant

I am not postmenopausal.

BMI is in 'normal' category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims

Exclusion Criteria

I have gone through menopause.

You are pregnant or expecting to become pregnant (females only)

You have a pacemaker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

High-fat meal trial

Participants consume a high-fat meal and undergo vascular measurements and blood sampling

1 day

1 visit (in-person)

Stress trial

Participants undergo a stress task with vascular measurements and blood sampling

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the trials

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Fat Meal
• Stress

Trial Overview

The study aims to explore the impact of body composition on cardiovascular health by having participants undergo two different lab visits: one involving consumption of a high-fat meal and another involving a stress task.

How Is the Trial Designed?

Group I: Stress trial Experimental Treatment 1 Intervention

During the "Stress trial", participants will report fasted and undergo a stress task where they may experience mental stress.

Group II: High-fat meal trial Experimental Treatment 1 Intervention

During the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls.

Who Is Running the Clinical Trial?

Ball State University

Lead Sponsor

Trials

10

Recruited

670+

Published Research Related to This Trial

In a study involving 10 healthy males, consuming a high-fat meal did not affect the body's hemodynamic stress responses during psychological stress tasks, indicating that fat intake may not influence cardiovascular reactivity as previously thought.

The research showed that both hemodynamic reactivity and recovery remained stable across multiple stress tasks, suggesting that meal fat content does not impact the body's ability to recover from stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence that meal fat content does not impact hemodynamic reactivity to or recovery from repeated mental stress tasks. Poitras, VJ., Slattery, DJ., Gurd, BJ., et al.[2014]

In a study involving 21 healthy young adults, consuming a high-fat breakfast before a mental stress task was found to reduce oxygenation in the pre-frontal cortex, suggesting that high-fat intake may impair brain function during stress.

Despite similar cardiovascular responses between high-fat and low-fat meals, the high-fat breakfast negatively affected cortical perfusion, highlighting the potential risks of high-fat diets during stressful situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fat Consumption Attenuates Cortical Oxygenation during Mental Stress in Young Healthy Adults. Baynham, R., Lucas, SJE., Weaver, SRC., et al.[2023]

Chronic mild unpredictable stress (CMS) in rats led to increased insulin levels, higher plasma lipid concentrations, and vascular changes, indicating that stress can negatively impact cardiovascular health regardless of diet.

A hypercaloric diet (HD) caused dyslipidemia but did not affect glucose metabolism or vascular function, suggesting that while diet can influence lipid levels, the effects of stress on vascular health are more pronounced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic stress, but not hypercaloric diet, impairs vascular function in rats. Neves, VJ., Moura, MJ., Almeida, BS., et al.[2022]

Elderly patients with coronary artery disease (CAD) showed higher carotid intima-media thickness (IMTc) and impaired flow-mediated vasodilation (FMD) compared to healthy elderly subjects, indicating worse vascular health.

After a high-fat meal, both groups experienced a significant decrease in FMD, but CAD patients had a greater decline, suggesting that their impaired endothelial function may be exacerbated by postprandial triglyceride metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of postprandial hypertriglyceridemia on the endothelial function in elderly patients with coronary heart disease]. Liu, L., Zhao, SP., Gao, M.[2006]

In a study involving 30 healthy participants, consuming a single high-fat meal led to increased cardiovascular reactivity, as shown by higher blood pressure and total peripheral resistance compared to a low-fat meal.

These results suggest that even one high-fat meal can negatively impact cardiovascular function, highlighting potential risks associated with high-fat diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A high-fat meal increases cardiovascular reactivity to psychological stress in healthy young adults. Jakulj, F., Zernicke, K., Bacon, SL., et al.[2023]

A balanced high-fat diet (HFD) consisting of equal parts saturated (SFA), monounsaturated (MUFA), and polyunsaturated (PUFA) fatty acids led to significant improvements in body composition, inflammation, and vascular function in obese premenopausal women, with a 6% increase in fat oxidation and a 2.5% decrease in body fat.

Supplementing the balanced HFD with specific 18C fatty acids, such as stearate and linoleate, further enhanced reductions in inflammatory markers, particularly a 74% decrease in IFNγ with stearate and a 31% decrease in PAI-1 with linoleate, suggesting targeted dietary fat modifications can improve cardiovascular disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consuming a balanced high fat diet for 16 weeks improves body composition, inflammation and vascular function parameters in obese premenopausal women. Silver, HJ., Kang, H., Keil, CD., et al.[2021]

A very-low-carbohydrate, high-saturated-fat diet (LC) did not negatively affect brachial artery flow-mediated dilatation (FMD), indicating it may not impair endothelial function after 8 weeks of weight loss in 99 participants.

Both the LC and a high-carbohydrate, low-saturated-fat diet (HC) showed improvements in cardiovascular disease risk markers, but the LC resulted in greater weight and abdominal fat loss, while the HC led to more significant reductions in LDL cholesterol and C-reactive protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of weight loss from a very-low-carbohydrate diet on endothelial function and markers of cardiovascular disease risk in subjects with abdominal obesity. Keogh, JB., Brinkworth, GD., Noakes, M., et al.[2023]

In a study of 58 healthy women, those with recent daily stressors showed heightened inflammatory responses to a high oleic sunflower oil meal, making it comparable to the responses seen after a high saturated fat meal, indicating that stress can significantly influence inflammation.

Women with a history of major depressive disorder (MDD) exhibited higher post-meal blood pressure responses, suggesting that both stress and MDD history can exacerbate inflammatory and cardiovascular responses to dietary fats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression, daily stressors and inflammatory responses to high-fat meals: when stress overrides healthier food choices. Kiecolt-Glaser, JK., Fagundes, CP., Andridge, R., et al.[2019]

In a study involving 10 healthy men, both acute mental stress and high-fat meal consumption were found to increase endothelial function (measured by flow-mediated dilatation) when experienced together, contrary to previous findings that suggested impairment from either factor alone.

The study showed that while high-fat meals raised plasma triglycerides, mental stress did not affect triglyceride levels, indicating that the interaction between stress and meal type may enhance vascular responses rather than impair them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combined influence of fat consumption and repeated mental stress on brachial artery flow-mediated dilatation: a preliminary study. Poitras, VJ., Slattery, DJ., Levac, BM., et al.[2015]

Ingestion of a high-fat meal (1200 kcal, 90 g fat) in 11 healthy subjects led to a significant increase in serum triglycerides and a temporary reduction in reactive hyperaemia, indicating a short-term impairment in resistance vessel function.

Despite the observed impairment in vascular reactivity after the meal, there were no signs of increased oxidative stress, as total plasma antioxidant capacity and plasma peroxide levels remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-fat meal on resistance vessel reactivity and on indicators of oxidative stress in healthy volunteers. Schinkovitz, A., Dittrich, P., Wascher, TC.[2019]

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