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Effect of Stevioside in Postpandrial Glucose in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01488383
Recruitment Status : Withdrawn (not i)
First Posted : December 8, 2011
Last Update Posted : September 9, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Hyperglycemia Hypertension Drug: Purified extract of Rebaudina Stevia-Stevioside Drug: Sodium saccharin

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Study Start Date : September 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. change in blood pressure [ Time Frame: at baseline and and at third hour after intake ]
    Change in blodd pressure after treatment

  2. 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

  3. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488383

Basque Public Health Service-Osakidetza (Lakuabizkarra primary care center and Txagorritxu hospital)
Vitoria-Gasteiz, Alava, Spain, 01009
Sponsors and Collaborators
Basque Health Service
More Information

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
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Antxon Apiñaniz Fernández de LArrinoa, Basque Health Service:
Blood glucose
Anti hypertensive agents
Anti hypertensive drugs
Anti hypertensive

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents