Overview

Effect of Stevioside in Postpandrial Glucose in Healthy Adults

Status:
Withdrawn
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Basque Health Service
Treatments:
Antihypertensive Agents
Criteria
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.