The acute effects of capsaicin on metabolism and thermogenesis in healthy adult females – a clinical trial

Phase 1

Recruiting

Conditions: metabolic syndrome
Metabolic and Endocrine - Metabolic disorders

Registration Number: ACTRN12624000014550

Lead Sponsor: a Trobe university

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 16

Inclusion Criteria

1.Healthy with no medical conditions (no diagnosed medical conditions that require the person to take prescription medication)
To eliminate different hormone patterns or altered carbohydrate metabolism that has been seen in disease states (such as diabetes), which ultimately could affect the final results.
2.Must be available for morning testing (up to 5 hours) on four individual days one week apart to cover the average oestrous cycle
3.Willingness to fast overnight.
4.Adult females with healthy BMI (18.5 -24.9 kg/m2) BMI is used to estimate the amount of fat and gives a healthy weight range related to individual height.
To minimize any underlying metabolic disorders
5.Ability to tolerate oral ingestion of capsaicin determined by previous ingestion of capsicum containing foods/supplements.

Exclusion Criteria

1.Diagnosis of any medical conditions
Disease states such as diabetes can alter participants’ metabolism. This would affect the researcher’s ability to determine the full effect capsaicin has on lipid and carbohydrate metabolism
2.Must be able to understand and comprehend instructions given to them in English, as determined by the researcher.
There will not be translator available to assist participants during testing.
3.Taking any regular medications for a diagnosed medical condition
Metabolism (lipid and carbohydrate) can be affected by different medications and could interfere with obtaining accurate results.
4.Inability to tolerate or experience of adverse effects from capsaicin or capsaicin containing products
Participants who cannot tolerate or experience adverse effects from capsaicin are excluded from the experiment.
5.Participants who have never ingested capsaicin or capsaicin containing product will be excluded from the experiment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brown adipose tissue thermogenesis[infrared thermography. Change from baseline with measures at baseline, after glucose ingestion and at 15-minute intervals for a total of 90 minutes after ingestion of the supplement at each scheduled visit ]

Secondary Outcome Measures

Name	Time	Method
respiratory exchange ratio[expired gas analysis will be done using ParvoMedics respiratory gas analyser giving levels of oxygen and carbon dioxide from which the expiatory exchange ratio is calculated. gaseous exchange measures at baseline, after glucose ingestion and at 15-minute intervals for a total of 90 minutes after ingestion of supplement at each scheduled visit.];Blood glucose level[finger prick and glucometer measures at baseline, after glucose ingestion and at 15-minute intervals for a total of 90 minutes after ingestion of supplement at each scheduled visit.]