Effect of Stevioside in Postpandrial Glucose in Healthy Adults
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.
|Hyperglycemia Hypertension||Drug: Purified extract of Rebaudina Stevia-Stevioside Drug: Sodium saccharin|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of the Effect on Postpandrial Capillary Blood Glucose Between Oral Stevioside Versus Saccharin in Healthy Adults.|
- change in capillary blood glucose levels [ Time Frame: at baseline and and at first hour after intake ]Change in capillary blood glucose levels after treatment
- change in blood pressure [ Time Frame: at baseline and and at third hour after intake ]Change in blodd pressure after treatment
- feeling of fullness, hunger and satiety after intake [ Time Frame: At baseline and and at third hour after intake ]feeling of fullness, hunger and satiety after treatment
- Adverse reactions of treatments (nausea, diarrhea, vomiting, allergic signs) [ Time Frame: After intake ]To describe and compare the adverse reactions of each treatment nausea, diarrhea, vomiting, allergic signs.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Stevioside capsules 200mg
Capsules of 200mg Stevioside
Drug: Purified extract of Rebaudina Stevia-Stevioside
volunteers will take only one capsule of stevioside (one day), and then corresponding measurements will be performed.
Other Name: Gycostevia-95
Active Comparator: Sodium Saccharin 250 capsules
Capsules of 250mg Saccharin
Drug: Sodium saccharin
Volunteers will take one capsule of saccharin 250mg (one day) and then, corresponding measurements will be performed
Other Name: Saccharin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01488383
|Basque Public Health Service-Osakidetza (Lakuabizkarra primary care center and Txagorritxu hospital)|
|Vitoria-Gasteiz, Alava, Spain, 01009|