GLYCEMIC RESPONSE AFTER CONSUMPTION OF FRENCH BREAD WITH WHOLE OR GROUND FLAXSEEDS IN PEOPLE WITH TYPE 2 DIABETES MELLITUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Capillary blood glucose concentration
研究概览
简要总结
This study aimed to evaluate the effect of consuming a portion of French bread combined with whole or ground flaxseed on the glycemia of people with DM 2 in a randomized, crossover clinical trial conducted with 16 people with DM 2 who were not using insulin.
The main questions of the study were:
- Is flaxseed able to control the glycemia of people with type 2 diabetes?
- What is the best way to consume flaxseed to control the glycemia of people with type 2 diabetes?
The 3 types of bread (whole flaxseed, ground flaxseed and control) were evaluated in interventions, with a 7-day interval between them, for the consumption of the bread and evaluation of the behavior of the glycemia and insulin curve.
详细描述
This study aimed to evaluate the effect of consuming a portion of French bread combined with whole or ground flaxseed on the blood glucose levels of people with DM 2 in a randomized, crossover clinical trial conducted with 16 people with DM 2 who were not taking insulin.
The main questions of the study were:
- Is flaxseed able to control the blood glucose levels of people with type 2 diabetes?
- What is the best way to consume flaxseed to control the blood glucose levels of people with type 2 diabetes? People with type 2 diabetes mellitus participated in the study, divided into three groups for random consumption of the breads: French bread without flaxseed (control bread), French bread with 30g of whole flaxseed, and French bread with 30g of ground flaxseed. The design was crossover and had a 7-day washout. Capillary blood glucose levels were monitored during fasting and at 15, 30, 60, 90 and 120 minutes after ingestion of the breads, while serum glucose and insulin levels were measured during fasting and at peak blood glucose levels, at 60 minutes. In addition, sociodemographic and clinical data (medication use, duration of DM2, bowel habits, sleep, and physical activity), nutritional status, and pre-intervention food consumption with a 24-hour dietary recall were evaluated. The data were analyzed in the R statistical software, through the Shapiro-Wilk normality test, one-way ANOVA, with Tukey or Kruskal-Wallis post-hoc. The analyses had a significance level of 5%.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The selection included individuals with DM 2
- •Of both sexes
- •Adults and elderly individuals without risk of dysphagia
- •Aged 18 years or older
- •Without allergies to the test foods
- •With the habit of having breakfast (≥4 days a week, with an intake of ≥100 kcal within two hours of waking up)
- •Availability of time for the days planned for the research.
排除标准
- •The exclusion criteria were applied to individuals diagnosed with another type of Diabetes
- •Using exogenous insulin
- •Pregnant or lactating women
- •With diseases that affect taste
- •The gastrointestinal system, and who reported the last intestinal frequency according to the Bristol scale 1, 2, 5, 6 and 7.
结局指标
主要结局
Capillary blood glucose concentration
时间窗: In the 3 interventions, completed in 3 weeks.
Six capillary blood glucose tests were performed in each study intervention. Time 0 (zero) was the basal measurement, and the others were performed in the postprandial period at 15, 30, 90 and 120 minutes.
次要结局
- Insulin Concentration(In the 3 interventions, completed in 3 weeks.)
研究者
Laureana Q Barcelos
Mestre em Ciências da Saúde e da Vida
Universidade Francisca