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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02193438 |
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Date of registration:
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16/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Physiologic Effect of Spices Ingestion
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Scientific title:
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Physiologic Effect of Spices Ingestion |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02193438 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Maurice Beaumont, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nestlé |
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Name:
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Stéphanie Michlig Gonzalez, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nestlé |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy
- BMI: 19-25 kg/m2, = 60 kg body weight
- Moderate spicy food eaters
- Having signed the informed consent.
Exclusion Criteria:
- Any gastrointestinal disorder
- Subject sensitive or not used to eat spicy food
- Smokers
- Subject with beard or mustache
- Abnormal thyroid function
- Intake of medication that could affect body weight and/or energy expenditure
- Weight loss > 5% in the last 3 months
- Under antibiotics or regular treatments (medical or nutritional program) affecting
body weight, appetite, energy expenditure, lipid-lowering, hypertension or
inflammation or glucose control for the last 3 months or taking hormone replacement
therapy
- History of allergy
- Physical activity level > 300 min of moderate or intense exercise per week
- Have a alcohol consumption higher than than 1 drink/day
- Consumption of illicit drugs
- Subject who cannot be expected to comply with the study procedures, including
consuming the test products
- Currently participating or having participated in another clinical trial during the
last 4 weeks prior to the beginning of this study
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Other: Spices intake
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Other: Placebo
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Primary Outcome(s)
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Resting energy expenditure
[Time Frame: change from baseline to 90 minutes following product intake]
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Heart rate variability
[Time Frame: Change from baseline to 90 minutes following product intake]
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Secondary Outcome(s)
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Facial skin temperature modification
[Time Frame: Change from baseline to 90 minutes following product intakeover 90 min]
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Blood pressure
[Time Frame: every 15 minutes over 90 minutes of recording following product intake]
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Substrat oxidation
[Time Frame: Change from baseline to 90 minutes following product intake]
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Secondary ID(s)
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10.24.MET
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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