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WithdrawnNCT02138630Updated Jun 22, 2022

Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 2)

An interventional study of Capsaicin and Placebo in Metabolism and Exercise, 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 Withdrawn at 1 site in Canada.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 2022-06-22.

Sponsored by University of Prince Edward Island · Not applicable, Interventional, and Other

Why this study was withdrawn
Project abandoned
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
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. Owing to the fact that these changes are believed to be driven by catecholamine release and alterations in fat oxidation, there is growing belief that capsaicin may also offer potential ergogenic benefits (performance enhancement) during exercise, similar to the affect of caffeine, which works through similar pathways. 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.

Although there are some indications that capsaicinoid ingestion may alter factors associated exercise performance (such as increased fat oxidation for glucose sparing), to date these studies have primarily used very low exercise intensities wherein these effects are typically unnecessary, and results are not generalizable to the typical race intensities of endurance sport competition. Performance measures have also been a noticeably absent outcome from research to date.

Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of causing intensity to go up 3) During sustained aerobic activity approaching the aerobic threshold alterations in substrate use will be minimal (but possibly meaningful in regard to performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects observed for more prolonged exposure in phase 1.

02

Conditions studied

  • Metabolism
  • Exercise

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Keywords

  • Exercise
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

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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

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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

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

  • Experimental
    Capsaicin

    Single Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise

    Dietary Supplement: Capsaicin

Interventions

  • Dietary supplementCapsaicin

    Also known as: Capsimax

  • Dietary supplementPlacebo

    Sugar capsule

06

What researchers measure

Primary outcomes

  1. Performance

    Exercise: Time to exhaustion on a cycle ergometer at controlled relative intensity

    Time frame: 2 to 4 hours

Secondary outcomes

  1. Substrate Use

    Measurement of expired gases

    Time frame: 2 to 4 hours

07

Study locations

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02138630
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 14, 2014
Start date
Jun 2014
Primary completion
Jan 2016 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jun 22, 2022

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Capsaicin

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