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临床试验/NCT06200272
NCT06200272已完成不适用

Effect of Whole-Wheat Bread Enriched With Carob Molasse Pose Flour and Germ On Healthy Volunteers' Glycemic Response and Antioxidant Capacity

Toros University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Whole wheat bread and blood TOS level at 0th minute

研究概览

简要总结

Test with standard whole wheat bread (germ and CMP added); Its effect on glycemic response and antioxidant capacity in healthy adults will be examined. For this purpose, adult individuals; will be carried out with 20 volunteer individuals between the ages of 19-35 years, who do not have acute or chronic diseases and whose Body Mass Index (BMI) value is between 18.5-24.9 kg/m2. Exclusion criteria will include using prescription drugs and/or nutritional supplements, being pregnant or lactating, excessive alcohol consumption (>2 drinks/day)/smoking, being in the menstrual period for female individuals, and being allergic to the foods to be used in the study. Individuals participating in the study will come to the research center twice in total, one week apart, to consume the bread produced. After eating their usual dinner the night before the test, individuals will be able to fast for 10-12 hours and drink only water during this period. Basal/fasting blood samples will be taken from individuals who come to the research center following fasting. The bread will be consumed within 10 minutes and venous blood samples will be taken by the nurse in charge at 30, 60, 120, and 180 minutes. During these three hours, individuals will be ensured not to leave the research center or consume any other food. Blood Glucose, Total Antioxidant Level (TAS), and Total Oxidant Level (TOS) values will be checked in the blood samples.

Blood Glucose, Total Antioxidant Level (TAS), and Total Oxidant Level (TOS) values will be statistically evaluated in the blood samples of individuals who consume standard whole wheat bread and the test whole wheat bread developed by us. If the results are found to be statistically significant, consuming the bread produced will play an important role in preventing chronic diseases such as obesity, diabetes, and cardiovascular diseases.

On the other hand; by adding CMP and germ, which are not currently evaluated, to the bread formulation, this study not only contributes to the prevention of food waste and sustainability by using low-cost food industry by-products but also enables the development of a bread-type with high nutritional value in terms of antioxidant-rich active ingredients, vitamins and dietary fiber.

详细描述

Bread is a traditional staple food widely consumed all over the world. In our country, whose diet is based on grain, the flour used in bread making is subjected to the refining process; The bran and germ parts are largely lost, resulting in a decrease in the nutritional value of the bread and an increase in the glycemic index and load. Therefore, consuming high amounts of bread containing refined flour has been associated with an increase in chronic diseases such as obesity, diabetes, and cardiovascular diseases. To reduce or eliminate this effect; In recent years, different nutritional enrichment studies aimed at reducing the health consequences mentioned above by improving the nutritional content of daily consumed bread have increasingly continued. In this study; Bread will be produced by adding germ (obtained after processing the wheat grain), which has a high antioxidant capacity and is rich in vitamins and dietary fiber, and carob pulp (Carob Molasses Pulp, CMP), which is not considered as waste after the production of carob molasses, to the formulation of whole wheat bread, which has been widely consumed in recent years. . The most suitable formulation will be determined by determining the chemical (moisture, ash, protein, fat, total and resistant starch, and antioxidant capacity) and sensory properties (appearance, crust color, taste, smell, chewiness, etc.) of the bread produced in this way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • no acute or chronic disease
  • no prescription drugs and/or nutritional supplements
  • no pregnant or lactating
  • no alcohol or excessive alcohol consumption (<2 drinks/day)
  • no smoking,
  • BMI value between 18.5-24.9 kg/m2
  • no in the menstrual period for female individuals
  • no gluten enteropathy
  • no insulin resistance as a result of endocrinological examination and biochemical tests
  • no allergic reaction to carob
  • signed the Informed Volunteer Consent Form
  • aged between 19 and 35 years.

排除标准

  • having an acute or chronic disease
  • using prescription drugs and/or nutritional supplements
  • being in pregnancy and lactation
  • consuming excessive alcohol (>2 drinks/day)
  • BMI value under 18.5 or above 24.
  • being in the menstrual period for female individuals
  • having gluten enteropathy
  • having insulin resistance as a result of endocrinological examination and biochemical tests
  • having an allergic reaction to carob
  • not signed the Informed Volunteer Form,
  • aged under 19 years or above 35 years of age

结局指标

主要结局

Whole wheat bread and blood TOS level at 0th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood glucose level at 60th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TAS level at 60th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TOS level at 120th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood glucose level at 180th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TOS level at 180th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TOS level at 180th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TAS level at 180th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood glucose level at 0th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood glucose measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood glucose level at 0th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood glucose measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TAS level at 0th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TAS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TAS level at 0th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TAS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TOS level at 0th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood glucose level at 30th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TAS level at 30th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TAS level at 180th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TOS level at 30th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood glucose level at 60th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TAS level at 60th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood glucose level at 120th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood glucose level at 120th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TAS level at 120th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TAS level at 120th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TOS level at 120th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood glucose level at 30th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TAS level at 30th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TOS level at 30th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread and blood TOS level at 60th minute

时间窗: One day

Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood TOS level at 60th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

Whole wheat bread (added CMP and germ) and blood glucose level at 180th minute

时间窗: One day

Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.

次要结局

  • Measurements of Body Fluid(1 day)
  • Chemical analysis of test and control breads' protein content (%)(up to 8 weeks)
  • Measurements of weight (kg) and height (cm)(1 day)
  • Circumferences measurements(1 day)
  • Chemical analysis of test and control breads' moisture content (%)(up to 8 weeks)
  • Chemical analysis of test and control breads' specific volume (m3/kg or m3·kg-1)(up to 8 weeks)
  • Chemical analysis of test and control breads' antioxidant capacity (μg TE/g)(up to 8 weeks)
  • Sociodemographic information form of participants eating whole wheat bread and whole wheat bread (added CMP and germ)(One day)
  • Determination of food consumption(One day)
  • Measurements of Basal Metabolic Rate (kkal)(1 day)
  • Chemical analysis of test and control breads' colorimetric assays (EBC)(up to 8 weeks)
  • Measurements of Body Fat(1 day)
  • Chemical analysis of test and control breads' lipid content (%)(up to 8 weeks)
  • Chemical analysis of test and control breads' ash content (%)(up to 8 weeks)
  • Chemical analysis of test and control breads' in vitro starch digestion rate (%) and glycemic index(up to 8 weeks)
  • Chemical analysis of test and control breads' total phenolic content (mg GAE / g)(up to 8 weeks)
  • Chemical analysis of test and control breads' total starch analysis (g)(up to 8 weeks)
  • Chemical analysis of test and control breads' resistant starch (g)(up to 8 weeks)
  • Chemical analysis of test and control breads' moisture (baking) loss (%)(up to 8 weeks)

研究者

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

Eda Parlak

Asst. Prof.

Toros University

研究点 (2)

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