Hypertension Clinical Trial
Official title:
Comparison of the Effect on Postpandrial Capillary Blood Glucose Between Oral Stevioside Versus Saccharin in Healthy Adults.
Verified date | September 2015 |
Source | Basque Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
A natural sweetener (Stevia Rebaudina Bertoni) reduces blood glucose levels and blood
pressure according to various preclinical and clinical studies conducted worldwide. Since it
is not found many studies in the literature wich compares Stevia Rebaudiana with saccharin,
we've proposed a randomized crossover clinical trial comparing the effects on postprandial
capillary blood glucose and blood pressure in healthy adults.
Sample: healthy professionals from two health centers in Alava (Kakuabizkarra primary care
center and Txagorritxu hospital). Inclusion criteria: Professionals of two health centers of
Álava (Lakuabizkarra and Txagorritxu) and active employment status at the beginning of the
trial, weighing more than 50kg and age over 18 years.
Intervention: 200mg capsules of Stevia or 250mgcapsules of saccharin. Measurements:
Capillary blood glucose and blood pressure, fasting and after eating. Evaluation of satiety,
hunger and fullness by questionnaire after intake, and at the end of the day.
Statistical analysis: Compare the postprandial capillary glucose levels between 8 am and 1
st hour, 2nd hour 3rd hour after intake between treatments by ANCOVA. We will also compare
blood pressure before and after intake between treatments. We will also compare by t test or
paired Wilcoxom (depending on the nature of the variable) the results of the questionnaire
after intake between treatments.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Professionals of sanitary centers in active working situation at start date of clinical trial. - Weight over 50kg. - Age over 18 years. Exclusion Criteria: - History of diabetes mellitus, arterial hypertension or hypercholesterolemia. - Obesity (BMI = 30kg/m2) - Cardiovascular disease. - Enrollment in other clinical trial with medicaments within three months. - Any endocrine disease other than diabetes. - Glucocorticoids treatment. - Pregnant women. - Herball allergy. - Autoimmune diseases. - Inflammatory bowel disease. - Allergy to sulfonamides. - Steven-Johnson syndrome. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Basque Public Health Service-Osakidetza (Lakuabizkarra primary care center and Txagorritxu hospital) | Vitoria-Gasteiz | Alava |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in capillary blood glucose levels | Change in capillary blood glucose levels after treatment | at baseline and and at first hour after intake | No |
Secondary | change in blood pressure | Change in blodd pressure after treatment | at baseline and and at third hour after intake | No |
Secondary | feeling of fullness, hunger and satiety after intake | feeling of fullness, hunger and satiety after treatment | At baseline and and at third hour after intake | No |
Secondary | Adverse reactions of treatments (nausea, diarrhea, vomiting, allergic signs) | To describe and compare the adverse reactions of each treatment nausea, diarrhea, vomiting, allergic signs. | After intake | Yes |
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