Effect of Stevioside in Postpandrial Glucose in Healthy Adults
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyperglycemia Hypertension |
Drug: Purified extract of Rebaudina Stevia-Stevioside Drug: Sodium saccharin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]Change in capillary blood glucose levels after treatment
- change in blood pressure [ Time Frame: at baseline and and at third hour after intake ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]feeling of fullness, hunger and satiety after treatment
- Adverse reactions of treatments (nausea, diarrhea, vomiting, allergic signs) [ Time Frame: After intake ] [ Designated as safety issue: Yes ]To describe and compare the adverse reactions of each treatment nausea, diarrhea, vomiting, allergic signs.
| Estimated Enrollment: | 120 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Antxon Apiñaniz | 945006800 | antxon.apinanizfernandez@osakidetza.net |
| Spain | |
| Basque Public Health Service-Osakidetza (Lakuabizkarra primary care center and Txagorritxu hospital) | Not yet recruiting |
| Vitoria-Gasteiz, Alava, Spain, 01009 | |
| Contact: Antxon Apiñaniz 945006800 antxon.apinanizfernandez@osakidetza.net | |
| Principal Investigator: Antxon Apiñaniz | |
| Sub-Investigator: Lucía Garate | |
| Sub-Investigator: Raquel Cobos | |
| Sub-Investigator: Erika Miranda | |
More Information
No publications provided
| Responsible Party: | Antxon Apiñaniz Fernández de LArrinoa, Primary health care physician, Basque Health Service |
| ClinicalTrials.gov Identifier: | NCT01488383 History of Changes |
| Other Study ID Numbers: | ST-01 |
| Study First Received: | December 7, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Basque Health Service:
|
Hyperglycemia Diabetes Blood glucose Hypertension |
Anti hypertensive agents Anti hypertensive drugs Anti hypertensive |
Additional relevant MeSH terms:
|
Hyperglycemia Hypertension Glucose Metabolism Disorders Metabolic Diseases Vascular Diseases |
Cardiovascular Diseases Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013