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Fatty Meal Challenge for Healthy Subjects
N/A
Waitlist Available
Led By Garret A FitzGerald, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Young: 18-30 years of age
Old: 55-75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study Summary
This trial is looking at how different sex, age, and conditions affect the human body's natural clocks (chronobiome).
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves consuming a fatty meal as an intervention in healthy subjects rather than testing medication or devices with known side effects profiles, no specific side effects are anticipated beyond normal individual variations to dietary intake.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Select...
I am between 55 and 75 years old.
Select...
My upper arm skin is healthy, with no injuries or breaks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent difference in the number of proteins with post-translational modifications found in blood samples from young versus old participants
Secondary outcome measures
Percent difference in environmental light exposure between young versus old participants
Percent difference in environmental light exposure between young versus old participants and by sex
Percent difference in physical activity between young versus old participants
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Fatty mealExperimental Treatment1 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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,040 Total Patients Enrolled
Garret A FitzGerald, MDPrincipal InvestigatorUniversity of Pennsylvania
10 Previous Clinical Trials
685 Total Patients Enrolled
Carsten C Skarke, MDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking alpha-blocker medication.I am between 18 and 30 years old.I have not taken any antibiotics in the last 6 months.I have been diagnosed with acid reflux before.I have a history of Raynaud's phenomenon.I am between 55 and 75 years old.I am either between 18-30 or 55-75 years old.My upper arm skin is healthy, with no injuries or breaks.I have diabetes.You have a pacemaker or implantable defibrillator in your body.I have had both of my breasts surgically removed.You drink more than two alcoholic drinks every day.You have a smartphone that you use.You are in good overall health.I have been diagnosed with severe sleep apnea.You have a history of serious mental health conditions like schizophrenia or severe intellectual disabilities.Your weight is within a certain range based on your height, and it shouldn't exceed a certain number.My liver function tests are not more than three times the normal limit.You are allergic to natural latex rubber, which is found in the bladder and tubing used in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Fatty meal
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research project incorporate participants aged eighty-five and above?
"Per the outlined prerequisites, participants must be between 18 and 75 years old to take part in this clinical trial."
Answered by AI
What is the patient population size of this trial?
"Affirmative. The data available on clinicaltrials.gov highlight that this experiment is actively recruiting patients, having been originally posted on the 5th of January 2020 and last updated on the 27th of January 2022. 48 individuals are needed at one medical facility to complete the trial's requirements."
Answered by AI
To whom is this clinical trial open for enrollment?
"In order to qualify for this medical trial, applicants must display signs of healthy aging and be aged between 18-75. To meet the full requirements of the clinical research, 48 individuals need to join in total."
Answered by AI
Is registration currently open for this clinical investigation?
"Affirmative. The clinical trial is at present seeking participants, which has been evidenced by the information accessible on clinicaltrials.gov. This research was initially posted on 5th January 2020 and last updated on 27th January 2022, searching for 48 patients from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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