Fatty Meal Challenge for Healthy Subjects

Overseen By Carsten Skarke, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Antibiotics, Alpha-blockers

Disqualifiers: Severe psychiatric illness, Shift work, Obstructive sleep apnea, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

I am between 55 and 75 years old.

My upper arm skin is healthy, with no injuries or breaks.

Own and use a smartphone

Exclusion Criteria

Nursing or pregnant (pregnancy will be repeatedly assessed at the beginning of each of the four inpatient visits, i.e. prior to the start of blood draws)

I am currently taking alpha-blocker medication.

I have not taken any antibiotics in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' chronobiome and baseline measurements

1 week

1 visit (in-person)

Fatty Meal Challenge

Participants consume a controlled high-fat meal to study its effect on the chronobiome

48 hours

Continuous monitoring

Follow-up

Participants are monitored for changes in physiological markers post-intervention

1 week

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?

Group I: Fatty meal Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A comprehensive review of 90 randomized controlled trials found that omega-3 polyunsaturated fatty acids (PUFAs) are associated with a higher likelihood of certain adverse effects, including diarrhea, dysgeusia (altered taste), and bleeding tendency, compared to placebo.

Despite these adverse effects, there were no serious adverse events reported related to omega-3 PUFA supplementation, suggesting that while they may cause some minor issues, they are generally safe and tolerable for most individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Chang, JP., Tseng, PT., Zeng, BS., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-2020-499b9

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12471356/

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.00006.2022

Complex 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 ...

4. gastrojournal.org gastrojournal.org/article/S0016-5085(20)30221-3/fulltext

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 ...

5. mdpi.com mdpi.com/1422-0067/26/13/6267

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12486747/

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 ...

7. fda.gov fda.gov/media/170783/download

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 ...

8. link.springer.com link.springer.com/article/10.1007/s40268-023-00448-0

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 ...

9. bmj.com bmj.com/content/361/bmj.k2139

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 ...