~6 spots leftby Jul 2025

Body Composition Effects for Vascular Health

Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ball State University
Must not be taking: Anti-inflammatories, Statins, Metformin, others
Disqualifiers: Cardiovascular disease, Diabetes, Rheumatoid arthritis, others
No Placebo Group

Trial Summary

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.

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.12345

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.14567

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.458910

Eligibility Criteria

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

I am between 18 and 50 years old.
You are not pregnant or expecting to become pregnant
I am not postmenopausal.
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Exclusion Criteria

I have gone through menopause.
You are pregnant or expecting to become pregnant (females only)
You have a pacemaker
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Trial Timeline

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

Treatment Details

Interventions

  • High-Fat Meal (Behavioural Intervention)
  • Stress (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Stress trialExperimental Treatment1 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 trialExperimental Treatment1 Intervention
During the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Ball State University- Nutrition Assessment LabMuncie, IN
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Who Is Running the Clinical Trial?

Ball State UniversityLead Sponsor

References

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]The effects of a very-low-carbohydrate, high-saturated-fat weight-loss diet (LC) on brachial artery flow-mediated dilatation (FMD) and markers of endothelial function are unknown.
Chronic stress, but not hypercaloric diet, impairs vascular function in rats. [2022]The aim of this study was to evaluate vascular and metabolic effects of chronic mild unpredictable stress (CMS) and hypercaloric diet (HD) without carbohydrate supplementation in rats. Male Sprague-Dawley rats were randomly assigned to four groups: Control, HD, CMS, and HD plus CMS. CMS consisted of the application of different stressors for 3 weeks. The rats were killed 15 days after CMS exposure. The HD group presented higher plasma lipid concentrations, without changes in fasting glucose concentration, glucose tolerance test, and vascular function and morphology, in comparison with the control group. Stressed rats presented higher fasting blood concentration of insulin, higher homeostasis model assessment index values and area under the curve in an oral glucose tolerance test, in comparison with non-stressed rats. CMS increased the plasma concentrations of corticosterone and lipids, and the atherogenic index values, without change in high-density lipoprotein level. CMS increased intima-media thickness and induced endothelium-dependent supersensitivity to phenylephrine, and lowered the relaxation response to acetylcholine in the thoracic aorta isolated from rats fed with control or HD, in comparison with non-stressed groups. CMS effects were independent of diet. In non-stressed rats, the HD induced dyslipidemia, but did not change glucose metabolism, vascular function, or morphology. The data from this study indicate that CMS promotes a set of events which together can contribute to impair function of the thoracic aorta.
[Influence of postprandial hypertriglyceridemia on the endothelial function in elderly patients with coronary heart disease]. [2006]To explore the changes of carotid atherosclerosis and the endothelial function after a high-fat meal in elderly patients with coronary artery disease (CAD).
Depression, daily stressors and inflammatory responses to high-fat meals: when stress overrides healthier food choices. [2019]Depression, stress and diet can all alter inflammation. This double-blind, randomized crossover study addressed the impact of daily stressors and a history of major depressive disorder (MDD) on inflammatory responses to high-fat meals. During two separate 9.5 h admissions, 58 healthy women (38 breast cancer survivors and 20 demographically similar controls), mean age 53.1 years, received either a high saturated fat meal or a high oleic sunflower oil meal. The Daily Inventory of Stressful Events assessed prior day stressors and the Structured Clinical Interview for DSM-IV evaluated MDD. As expected, for a woman with no prior day stressors, C-reactive protein (CRP), serum amyloid A (SAA), intercellular adhesion molecule-1 (sICAM-1) and vascular cell adhesion molecule-1 (sVCAM-1) were higher following the saturated fat meal than the high oleic sunflower oil meal after controlling for pre-meal measures, age, trunk fat and physical activity. But if a woman had prior day stressors, these meal-related differences disappeared-because the stressors heightened CRP, SAA, sICAM-1 and sVCAM-1 responses to the sunflower oil meal, making it look more like the responses to the saturated fat meal. In addition, women with an MDD history had higher post-meal blood pressure responses than those without a similar history. These data show how recent stressors and an MDD history can reverberate through metabolic alterations, promoting inflammatory and atherogenic responses.
A high-fat meal increases cardiovascular reactivity to psychological stress in healthy young adults. [2023]The consumption of high levels of saturated fat over the course of several weeks may lead to exaggerated cardiovascular reactivity. The consumption of a single high-fat meal has been associated with a transient impairment of vascular function. In a randomized, repeated measures, crossover study we tested whether the consumption of a single high-fat meal by healthy, normotensive participants would affect cardiovascular reactivity when compared with an isocaloric, low-fat meal. Thirty healthy participants ate a high-fat (42 g) and a low-fat (1 g) meal on 2 separate occasions, and their cardiovascular response to 2 standard laboratory stressors was measured. Systolic blood pressure, diastolic blood pressure, and total peripheral resistance were greater in participants following the consumption of the high-fat meal relative to the low-fat meal. The findings of the present study are consistent with the hypothesis that even a single high-fat meal may be associated with heightened cardiovascular reactivity to stress and offer insight into the pathways through which a high-fat diet may affect cardiovascular function.
Evidence that meal fat content does not impact hemodynamic reactivity to or recovery from repeated mental stress tasks. [2014]The magnitude (reactivity) and duration (recovery) of hemodynamic stress responses are predictive of cardiovascular risk, and fat intake has been shown to enhance hemodynamic reactivity to psychological stress tasks. The objective of this study was to determine the impact of a high-fat meal (HFM) on the magnitude and stability of hemodynamic stress reactivity and recovery. This was assessed by: (i) the peak changes from baseline to during stress for heart rate (HR); mean, systolic, and diastolic blood pressure; cardiac output; and total peripheral resistance; and (ii) the residual arousal in hemodynamic parameters at 2 points post-stress ("early" and "late" recovery). On different days, 10 healthy males (aged 23.2 ± 3.3 years) consumed either a HFM (54 g fat) or low-fat meal (LFM; 0 g fat) (∼1000 calories each), followed by 4 hourly 10-min stress tasks (mental arithmetic and speech tasks). Pre-stress (baseline) parameters did not differ between HFM and LFM conditions (all P > 0.05). Plasma triglycerides were greater following the HFM versus the LFM (P = 0.023). No reactivity or recovery parameters differed between meals (all P > 0.05). Stress reactivity and recovery parameters were stable over the 4 stress tasks (main effects of time, all P > 0.05), with the exception of HR (P
Fat Consumption Attenuates Cortical Oxygenation during Mental Stress in Young Healthy Adults. [2023]Mental stress has been associated with cardiovascular events and stroke, and has also been linked with poorer brain function, likely due to its impact on cerebral vasculature. During periods of stress, individuals often increase their consumption of unhealthy foods, especially high-fat foods. Both high-fat intake and mental stress are known to impair endothelial function, yet few studies have investigated the effects of fat consumption on cerebrovascular outcomes during periods of mental stress. Therefore, this study examined whether a high-fat breakfast prior to a mental stress task would alter cortical oxygenation and carotid blood flow in young healthy adults. In a randomised, counterbalanced, cross-over, postprandial intervention study, 21 healthy males and females ingested a high-fat (56.5 g fat) or a low-fat (11.4 g fat) breakfast 1.5 h before an 8-min mental stress task. Common carotid artery (CCA) diameter and blood flow were assessed at pre-meal baseline, 1 h 15 min post-meal at rest, and 10, 30, and 90 min following stress. Pre-frontal cortex (PFC) tissue oxygenation (near-infrared spectroscopy, NIRS) and cardiovascular activity were assessed post-meal at rest and during stress. Mental stress increased heart rate, systolic and diastolic blood pressure, and PFC tissue oxygenation. Importantly, the high-fat breakfast reduced the stress-induced increase in PFC tissue oxygenation, despite no differences in cardiovascular responses between high- and low-fat meals. Fat and stress had no effect on resting CCA blood flow, whilst CCA diameter increased following consumption of both meals. This is the first study to show that fat consumption may impair PFC perfusion during episodes of stress in young healthy adults. Given the prevalence of consuming high-fat foods during stressful periods, these findings have important implications for future research to explore the relationship between food choices and cerebral haemodynamics during mental stress.
The combined influence of fat consumption and repeated mental stress on brachial artery flow-mediated dilatation: a preliminary study. [2015]Experienced separately, both acute mental stress and high-fat meal consumption can transiently impair endothelial function, and the purpose of the present study was to investigate their combined impact. On four separate days, 10 healthy men (23 years old) underwent brachial artery flow-mediated dilatation (FMD) tests, before and hourly for 4 h post-consumption of a high-fat (HFM; 54 g fat) or low-fat meal (LFM; 0 g fat; each meal ∼ 1000 calories), with hourly mental stress (mental arithmetic, speech) or control (counting) tasks (conditions HFM+S, LFM+S, HFM and LFM). Data are presented as means ± SD. Plasma triglycerides increased and remained elevated after the high-fat but not the low-fat meal (P = 0.004) and were not affected by mental stress (P = 0.329). Indices of stress reactivity increased during mental stress tasks (mean arterial pressure, ∼ 20 mmHg; heart rate, ∼ 22 beats min(-1); salivary cortisol, ∼ 2.37 nmol l(-1); and plasma noradrenaline, ∼ 0.17 ng ml(-1)) and were not influenced by meal (P > 0.05). There was no effect of the type of meal on FMD (P = 0.562); however, FMD was 4.5 ± 0.5% in the control conditions and 5.8 ± 0.6% in the mental stress conditions (P = 0.087), and this difference was significant when normalized for the shear stress stimulus (FMD/area under the curve of shear stress, P = 0.045). Overall, these preliminary data suggest that postprandial FMD was augmented with mental stress irrespective of meal type. These results are contrary to previous reports of impaired endothelial function after mental stress or fat consumption independently and highlight the need to further investigate the mechanisms underlying the interactions between these factors.
Effects of a high-fat meal on resistance vessel reactivity and on indicators of oxidative stress in healthy volunteers. [2019]High fat meals postprandially impair macrovascular endothelial function and a link to increased oxidative stress is suggested. Few information, on the other hand, exists on the effect of postprandial hyperlipidaemia on resistance vessel function. Under normal circumstances this vascular bed regulates tissue perfusion and, by controlling flow, impacts on macrovascular nitric oxide formation. The impact of a high fat meal (1200 kcal, 90 g fat, 46 g protein and 47 g carbohydrates) on postprandial resistance vessel reactivity and on indicators of oxidative stress was studied in 11 healthy subjects by venous-occlusion plethysmography using another six subjects as time control group. Ingestion of the test meal resulted in a pronounced increase of serum triglycerides from 1.05 +/- 0.61 mmol l(-1) in the fasting state to peak postprandial values of 1.94 +/- 0.41 mmol l(-1) (P
10.United Statespubmed.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]Inflammation, insulin resistance and vascular dysfunction characterize obesity and predict development of cardiovascular disease (CVD). Although women experience CVD events at an older age, vascular dysfunction is evident 10years prior to coronary artery disease. Questions remain whether replacing SFA entirely with MUFA or PUFA is the optimal approach for cardiometabolic benefits. This study tested the hypotheses that: a) body composition, inflammation and vascular function would improve with a high fat diet (HFD) when type of fat is balanced as 1/3 SFA, 1/3 MUFA and 1/3 PUFA; and b) body composition, inflammation and vascular function would improve more when balanced HFD is supplemented with 18C fatty acids, in proportion to the degree of 18C unsaturation.