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临床试验/NCT05484323
NCT05484323已完成不适用

Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses: A Randomized Clinical Trial in Healthy Humans

Agricultural University of Athens1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Capillary blood glucose responses

研究概览

简要总结

This study investigated the effects of cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses.

详细描述

This study examined the short-term effects of cookies containing 0 and 2.5 g Spirulina on postprandial glycemic and insulin responses, arterial blood pressure and subjective appetite

研究设计

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

盲法说明

double-blind both the participant and investigator were masked. A researcher not involved in data analyses was responsible for participant allocation and test food consumption

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •non-smoking
  • •men and women
  • •body mass index between 18 and 24.9 kg/m2

排除标准

  • •severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endrocrine conditions)
  • •gastrointestinal diseases
  • •pregnancy
  • •lactation
  • •competitive sports
  • •alcohol abuse
  • •drug dependency

研究组 & 干预措施

Glucose as reference food

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Glucose as reference food (Other)

Glucose as reference food

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: White bread (Other)

Glucose as reference food

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 0 g spirulina (Diagnostic Test)

Glucose as reference food

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 2.5 g spirulina (Other)

White bread

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: White bread (Other)

White bread

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 0 g spirulina (Diagnostic Test)

White bread

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 2.5 g spirulina (Other)

White bread

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Glucose as reference food (Other)

Cookie containing 0 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Glucose as reference food (Other)

Cookie containing 0 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: White bread (Other)

Cookie containing 0 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 0 g spirulina (Diagnostic Test)

Cookie containing 0 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 2.5 g spirulina (Other)

Cookie containing 2.5 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Glucose as reference food (Other)

Cookie containing 2.5 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: White bread (Other)

Cookie containing 2.5 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 0 g spirulina (Diagnostic Test)

Cookie containing 2.5 g spirulina

Experimental

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

干预措施: Cookie containing 2.5 g spirulina (Other)

结局指标

主要结局

Capillary blood glucose responses

时间窗: 2 hours

Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2 hr glucose tolerance test

次要结局

  • Salivary insulin responses(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aimilia Papakonstantinou

Assistant Professor

Agricultural University of Athens

研究点 (1)

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