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?

Most of the time, body weight is evaluated by looking at the ratio of your weight to your height. This measurement is called body mass index or BMI. However, BMI does not account for what your body is actually made up of (e.g., body fat versus muscle), which may be more important for determining cardiovascular disease risk. The investigators aim to understand vascular health in females with a "healthy" BMI with differing amounts of body fat and muscle mass. We will have participants come to the lab for two different study visits. At one visit, participants will eat a meal high in fat, and at the other visit, participants will undergo a stress task.

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 it safe to consume high-fat meals in terms of cardiovascular and stress-related effects?

Research shows that consuming a high-fat meal can temporarily increase blood pressure and affect blood flow during stress, but these effects were observed in healthy young adults and may not be harmful in the short term. However, high-fat meals can also increase inflammation, especially if combined with stress or a history of depression, which could be a concern for long-term health. ^{1 2 3 4 5}

How does the treatment in the Body Composition Effects for Vascular Health trial differ from other treatments for vascular health?

The treatment in this trial is unique because it involves a balanced high-fat diet with specific proportions of saturated, monounsaturated, and polyunsaturated fats, which may improve body composition, inflammation, and vascular function in obese premenopausal women. This approach contrasts with typical dietary recommendations that often focus on reducing fat intake, particularly saturated fats, to improve cardiovascular health. ^{3 4 6 7 8}

What data supports the effectiveness of the treatment High-Fat Meal, Stress for vascular health?

Research suggests that a high-fat meal can increase cardiovascular reactivity to stress, which may impair vascular function. Chronic stress alone has been shown to impair vascular function in rats, indicating that stress can negatively impact vascular health. ^{3 4 5 9 10}

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

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]

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 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 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]

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]

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]

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]

Citations

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Chronic stress, but not hypercaloric diet, impairs vascular function in rats. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Influence of postprandial hypertriglyceridemia on the endothelial function in elderly patients with coronary heart disease]. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Depression, daily stressors and inflammatory responses to high-fat meals: when stress overrides healthier food choices. [2019]

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

A high-fat meal increases cardiovascular reactivity to psychological stress in healthy young adults. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Evidence that meal fat content does not impact hemodynamic reactivity to or recovery from repeated mental stress tasks. [2014]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Fat Consumption Attenuates Cortical Oxygenation during Mental Stress in Young Healthy Adults. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The combined influence of fat consumption and repeated mental stress on brachial artery flow-mediated dilatation: a preliminary study. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Effects of a high-fat meal on resistance vessel reactivity and on indicators of oxidative stress in healthy volunteers. [2019]

10. United States 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. [2021]