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临床试验/NCT01488383
NCT01488383撤回不适用

Comparison of the Effect on Postpandrial Capillary Blood Glucose Between Oral Stevioside Versus Saccharin in Healthy Adults.

Basque Health Service1 个研究点 分布在 1 个国家开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
change in capillary blood glucose levels

研究概览

简要总结

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.

详细描述

State of the art: Excessive intake of calories and sugar diets cause weight gain and impaired glucose tolerance in healthy subjects (1). These diets raise postpandrial blood glucose and insulin levels and cause metabolic and hormonal changes that induce feelings of hunger and fat deposition. These diets are also associated with diseases such as diabetes, cardiovascular disease and cancer (2).

The origin of the artificial sweeteners dates back to 1879 with the accidental discovery of saccharin. France in 1902 and the United States in 1912 officially banned its use because of their lack of nutritional value. But Europe allowed the use of saccharin during sugar rationing in the world wars (3). In the past three decades has increased the consumption of these sweeteners as it has allowed many people suffering from obesity and / or diabetes restore some degree of palatability to foods (4).

Stevia rebaudiana Bertoni (Bertoni), common name "sweet herb of Paraguay" is a plant native to Paraguay and Brazil, known by Indians as Ka'a-he'e (sweet grass). Its leaves were used since pre-Columbian times for medicinal purposes and as a sweetener because of its sweet taste (5). Japan and Brazil have more than 20 years using it as a natural sweetener. The main sweet component of Stevia is the Stevioside, a glycoside 300 times sweeter than sucrose (7).

The benefits of stevia as a dietary supplement in humans are many: it is stable, non-caloric and offers a good dental health. In addition, no significant adverse effects have occurred from their use (6).

There have been several studies that compare the decline in blood glucose and insulin levels of Stevia versus many sweeteners. It has been administered to healthy and diabetic rats (8), healthy humans (9,10), obese (10) and diabetic (11).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Stevioside capsules 200mg

Experimental

Capsules of 200mg Stevioside

干预措施: Purified extract of Rebaudina Stevia-Stevioside (Drug)

Sodium Saccharin 250 capsules

Active Comparator

Capsules of 250mg Saccharin

干预措施: Sodium saccharin (Drug)

结局指标

主要结局

change in capillary blood glucose levels

时间窗: at baseline and and at first hour after intake

Change in capillary blood glucose levels after treatment

次要结局

  • 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)

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Antxon Apiñaniz Fernández de LArrinoa

Primary health care physician

Basque Health Service

研究点 (1)

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