Effect of Stevioside in Postpandrial Glucose in Healthy Adults

NCT01488383 | Withdrawn

• 1 other identifier: ST-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Hypertension

Keywords

Hyperglycemia; Diabetes; Blood glucose; Hypertension; Anti hypertensive agents; Anti hypertensive drugs; Anti hypertensive

Outcome Measures

Primary Outcomes (1)

• change in capillary blood glucose levels

  Change in capillary blood glucose levels after treatment

  at baseline and and at first hour after intake

Secondary Outcomes (3)

• change in blood pressure

  at baseline and and at third hour after intake

• feeling of fullness, hunger and satiety after intake

  At baseline and and at third hour after intake

• Adverse reactions of treatments (nausea, diarrhea, vomiting, allergic signs)

  After intake

Study Arms (2)

Stevioside capsules 200mg

EXPERIMENTAL

Capsules of 200mg Stevioside

Drug: Purified extract of Rebaudina Stevia-Stevioside

Sodium Saccharin 250 capsules

ACTIVE COMPARATOR

Capsules of 250mg Saccharin

Drug: Sodium saccharin

Interventions

Purified extract of Rebaudina Stevia-Stevioside DRUG

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

Also known as: Gycostevia-95

Stevioside capsules 200mg

Sodium saccharin DRUG

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

Also known as: Saccharin

Sodium Saccharin 250 capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Professionals of sanitary centers in active working situation at start date of clinical trial.
• Weight over 50kg.
• Age over 18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Basque Public Health Service-Osakidetza (Lakuabizkarra primary care center and Txagorritxu hospital)

Vitoria-Gasteiz, Alava, 01009, Spain

Location

MeSH Terms

Conditions

Hyperglycemia; Hypertension; Diabetes Mellitus

Interventions

Saccharin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary health care physician

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 8, 2011
• Study Start: September 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

ES (1)