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WithdrawnNCT02139852Phase 1Updated Jun 23, 2022

Capsaicinoid Ingestion, Human Metabolism and Exercise

An observational study in Metabolism, sponsored by University of Prince Edward Island. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-23.

Sponsored by University of Prince Edward Island · Observational

Why this study was withdrawn
Project abandoned
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
0
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking.

The investigators seek to understand the effect of 3 months capsaicinoid ingestion on alterations in body composition, traditional cardiovascular risk factors and cardiovascular function

Hypotheses:

  1. Continued use of capsaicinoids will alter resting metabolism substrate use, which will result in moderate (but clinically meaningful) alterations in body composition manifested as a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone. However, previous research suggests that these alterations will not be manifested in autonomic nervous tone assessed by changes in heart rate variability.
Read the detailed description

Project abandoned

02

Conditions studied

  • Metabolism
03

In context

Lead sponsor

University of Prince Edward Island is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Project abandoned

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects will be male or female
  • 18 yr -45yr and free from any known or suspected chronic conditions.
  • General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire

Exclusion criteria

Exclusion Criteria:

  • Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise.
  • Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion.
  • During baseline anthropometric assessment we will confirm that participants all fall within a typical range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese".
  • Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
0 participants (actual)
Patient registry
No

Interventions

06

What researchers measure

Primary outcomes

  1. Energy substrate use (Fat vs Carbohydrate contributions to metabolism)

    Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.

    Time frame: 10 weeks

Secondary outcomes

  1. Cardiovascular risk factors

    Vascular reactivity- endothelial function (Endopat), vascular stiffness (Pulse wave velocity), HRV (heart rate variability), Blood lipid/Glucose panel, blood pressure

    Time frame: 10 weeks

07

Study locations

1 site
  • UPEI
    Charlottetown, Prince Edward Island C1A4P3, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2014
First posted
May 15, 2014
Start
Jun 2014
Primary completionEst.
Jan 2016
CompletionEst.
Jan 2016
Last update
Jun 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02139852
Lead sponsor
University of Prince Edward Island
Collaborators
OmniActive Health Technologies
Responsible party
Dr. Jamie Burr (Assistant Professor, University of Prince Edward Island) — Principal investigator
First posted
May 15, 2014
Start date
Jun 2014
Primary completion
Jan 2016 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jun 23, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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