Effect of Stevioside in Postpandrial Glucose in Healthy Adults

NCT01488383 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-09-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Purified extract of Rebaudina Stevia-Stevioside

volunteers will take only one capsule of stevioside (one day), and then corresponding measurements will be performed.

DRUG

Sodium saccharin

Volunteers will take one capsule of saccharin 250mg (one day) and then, corresponding measurements will be performed

Sponsors & Collaborators

  • Basque Health Service

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488383 on ClinicalTrials.gov