Comparison of the Effect on Postpandrial Capillary Blood Glucose Between Oral Stevioside Versus Saccharin in Healthy Adults.
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
- 是
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
Capsules of 200mg Stevioside
干预措施: Purified extract of Rebaudina Stevia-Stevioside (Drug)
Sodium Saccharin 250 capsules
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
Antxon Apiñaniz Fernández de LArrinoa
Primary health care physician
Basque Health Service
