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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators piloted the characterization of the human chronobiome. Now, this line of research is extended to explore physiological chronobiome modulated by sex, age and under evoked conditions.

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.

Is the fatty meal challenge safe for humans?

Research on omega-3 fatty acids, which are often part of fatty meal challenges, shows they are generally safe but can cause mild side effects like diarrhea and taste changes. A study on alpha-linolenic acid, another component, reported no side effects in participants. ^{1 2 3 4 5}

How does the fatty meal challenge treatment differ from other treatments for appetite control?

The fatty meal challenge treatment is unique because it focuses on manipulating the composition of dietary fats (monounsaturated, polyunsaturated, and saturated fatty acids) to study their effects on appetite and eating behavior, rather than using a drug or standard therapy. This approach is novel as it explores dietary modifications to influence hunger and satiety, which is different from traditional appetite control methods. ^{6 7 8 9 10}

Research Team

Garret A FitzGerald, MD

Principal Investigator

University of Pennsylvania

Carsten C Skarke, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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 18 and 30 years old.

I am between 55 and 75 years old.

I am either between 18-30 or 55-75 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

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

Effects of peanut oil load on energy expenditure, body composition, lipid profile, and appetite in lean and overweight adults. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Supplementation with alpha-linolenic acid and inflammation: a feasibility trial. [2021]

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

Alteration of dietary fat intake to prevent weight gain: Jayhawk Observed Eating Trial. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Fish oil administration in older adults: is there potential for adverse events? A systematic review of the literature. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Manipulation of fatty acid composition in a high-fat meal does not result in differential alterations in appetite or food intake in normal weight females: A single-blind randomized crossover study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The degree of saturation of fatty acids influences post-ingestive satiety. [2022]

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

Effects of oral fat perception by modified sham feeding on energy expenditure, hormones and appetite profile in the postprandial state. [2011]

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

Hunger and satiety responses to high-fat meals of varying fatty acid composition in women with obesity. [2022]

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

Fatty acid chain length, postprandial satiety and food intake in lean men. [2010]