Fatty Meal Challenge for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how a fatty meal affects the body's internal clock, known as the chronobiome, in both young and older adults. Participants will consume a high-fat liquid meal to observe its influence on physiological rhythms. Researchers seek to understand differences based on sex, age, and other conditions. Individuals who are generally healthy, have a BMI up to 27.4, and own a smartphone might be a good fit. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on how diet impacts the body's natural rhythms.
Will I have to stop taking my current medications?
The trial requires that you do not take medications with alpha-blockers. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What prior data suggests that the fatty meal challenge is safe for healthy subjects?
Research has shown that fatty meal challenges are generally safe for healthy individuals. Studies involving omega-3 fatty acids, sometimes included in these meals, have found them to be mostly well-tolerated. While some individuals might experience mild side effects like diarrhea, these are uncommon.
One study found that consuming a high-fat meal caused some changes in the body, such as a slight increase in certain blood levels. However, these changes were not linked to any serious health issues in healthy participants.
Overall, evidence suggests that a fatty meal challenge is safe for most people, with only minor side effects reported.12345Why are researchers excited about this trial?
Researchers are excited about the fatty meal challenge because it explores how a high-fat meal affects the body's internal biological rhythms, known as the chronobiome, in both young and old individuals. Unlike typical studies that might focus on medication or dietary supplements, this trial uses an isocaloric controlled liquid high-fat meal, providing a unique way to understand dietary impacts. This approach could reveal new insights into how meal composition influences energy metabolism, which could eventually lead to personalized nutrition strategies based on age-related metabolic changes.
What evidence suggests that the fatty meal challenge is effective for studying the physiological chronobiome?
This trial will examine how a fatty meal modifies the physiological chronobiome in young and old participants. Research has shown that eating a fatty meal can affect the body's natural rhythms, known as the chronobiome. Studies have found that such meals alter the makeup of gut bacteria, influencing the production of important substances like short-chain fatty acids (SCFAs). These changes can impact how the body processes food and uses energy. Additionally, a high-fat diet can disrupt the body's internal clock, affecting metabolism and possibly leading to issues like fatty liver disease. While the research primarily aims to understand these effects, it offers valuable insights into how diet affects health.16789
Who Is on the Research Team?
Garret A FitzGerald, MD
Principal Investigator
University of Pennsylvania
Carsten C Skarke, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for healthy individuals, aged 18-30 or 55-75, with a BMI up to 27.4 and intact skin on the upper arm for blood pressure measurements. Participants must own a smartphone. Excluded are those doing shift work at night, with sleep apnea, liver disease, recent travel across time zones, drug use detected by urine tests, pregnant/nursing women, certain medical conditions like diabetes or heart device implants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment of participants' chronobiome and baseline measurements
Fatty Meal Challenge
Participants consume a controlled high-fat meal to study its effect on the chronobiome
Follow-up
Participants are monitored for changes in physiological markers post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Fatty meal challenge
Trial Overview
The study investigates how age and sex affect the body's chronobiome (biological rhythms) when challenged by a fatty meal in both young and older adults. It aims to understand physiological changes under specific conditions using ambulatory blood pressure monitoring.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
To study how a fatty meal modifies the physiological chronobiome in young and old, an isocaloric controlled liquid high fat meal (ICLHFM) will be consumed within 5 min. The ICLHFM contains an equivalent to 35% of the estimated total daily energy requirements (TDE), 60% of kcal delivered from fat while 13% come from protein and 27 % from carbohydrate.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Published Research Related to This Trial
Citations
Fatty Meal Challenge for Healthy Subjects
Trial Overview The study investigates how age and sex affect the body's chronobiome (biological rhythms) when challenged by a fatty meal in both young and older ...
The Gut Microbiota Axis in Social Jetlag: A Novel Framework ...
It shifts microbial structure, lowering key metabolite production like short-chain fatty acids (SCFAs). This effect worsens with high-fat or ...
3.
journals.physiology.org
journals.physiology.org/doi/full/10.1152/physrev.00006.2022?doi=10.1152/physrev.00006.2022Complex physiology and clinical implications of time- ...
As fasting continues, the increased delivery of fatty acids to the liver in conjunction with alterations in the insulin-to-glucagon ratio stimulates hepatic ...
Circadian Rhythms in the Pathogenesis and Treatment of ...
65. Gil-Lozano, M. ∙ Wu, W.K. ∙ Martchenko, A. ... High-fat diet ... subjects with nonalcoholic fatty liver disease: a comparison with healthy ...
Circadian Clock Deregulation and Metabolic Reprogramming
High-fat diet followed by fasting disrupts circadian expression of ... Changes of dietary fat and carbohydrate content alter central and peripheral clock in ...
Mixed-meal challenge differentially modulates metabolic ...
Mixed-meal challenge differentially modulates metabolic pathways in adipose tissue in healthy abdominally obese subjects with high versus low ...
Clinical Pharmacology Considerations for Food Effect ...
Food can increase or decrease drug exposure, impacting safety/efficacy. Assessing food effects helps understand drug exposure and provide ...
Unveiling the Influence of a High-Fat Meal on ...
Compared with the fasting state, healthy volunteers who consumed a high-fat meal showed a 24.8% increase in Cmax, a 35.2% increase in AUCt, and ...
Dietary fat and cardiometabolic health: evidence ...
This article takes a critical look at the evolution of scientific understanding about dietary fats and health, the difficulties of establishing public health ...
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