Clinical trial NCT06200272: Effect of Carob Molasse Pose Flour and Germ On Glycemic Response and Antioxidant Capacity
Official title: Effect of Whole-Wheat Bread Enriched With Carob Molasse Pose Flour and Germ On Healthy Volunteers' Glycemic Response and Antioxidant Capacity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Participants
Keywords: Carob molasses pulp
germ
bread
glycemic load
antioxidant capacity
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* having an acute or chronic disease
* using prescription drugs and/or nutritional supplements
* being in pregnancy and lactation
* consuming excessive alcohol (\>2 drinks/day)
* smoking
* BMI value under 18.5 or above 24.9. kg/m2
* 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

Primary outcomes:
measure: Whole wheat bread and blood glucose level at 0th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood glucose level at 0th minute
timeFrame: One day
measure: Whole wheat bread and blood TAS level at 0th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TAS level at 0th minute
timeFrame: One day
measure: Whole wheat bread and blood TOS level at 0th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TOS level at 0th minute
timeFrame: One day
measure: Whole wheat bread and blood glucose level at 30th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood glucose level at 30th minute
timeFrame: One day
measure: Whole wheat bread and blood TAS level at 30th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TAS level at 30th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TOS level at 30th minute
timeFrame: One day
measure: Whole wheat bread and blood TOS level at 30th minute
timeFrame: One day
measure: Whole wheat bread and blood glucose level at 60th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood glucose level at 60th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TAS level at 60th minute
timeFrame: One day
measure: Whole wheat bread and blood TAS level at 60th minute
timeFrame: One day
measure: Whole wheat bread and blood TOS level at 60th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TOS level at 60th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood glucose level at 120th minute
timeFrame: One day
measure: Whole wheat bread and blood glucose level at 120th minute
timeFrame: One day
measure: Whole wheat bread and blood TAS level at 120th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TAS level at 120th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TOS level at 120th minute
timeFrame: One day
measure: Whole wheat bread and blood TOS level at 120th minute
timeFrame: One day
measure: Whole wheat bread and blood glucose level at 180th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood glucose level at 180th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TAS level at 180th minute
timeFrame: One day
measure: Whole wheat bread and blood TAS level at 180th minute
timeFrame: One day
measure: Whole wheat bread and blood TOS level at 180th minute
timeFrame: One day
measure: Whole wheat bread (added CMP and germ) and blood TOS level at 180th minute
timeFrame: One day
Secondary outcomes:
measure: Sociodemographic information form of participants eating whole wheat bread and whole wheat bread (added CMP and germ)
timeFrame: One day
measure: Determination of food consumption
timeFrame: One day
measure: Measurements of weight (kg) and height (cm)
timeFrame: 1 day
measure: Measurements of Basal Metabolic Rate (kkal)
timeFrame: 1 day
measure: Measurements of Body Fat
timeFrame: 1 day
measure: Measurements of Body Fluid
timeFrame: 1 day
measure: Circumferences measurements
timeFrame: 1 day
measure: Chemical analysis of test and control breads' protein content (%)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' moisture content (%)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' specific volume (m3/kg or m3·kg-1)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' colorimetric assays (EBC)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' lipid content (%)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' ash content (%)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' total phenolic content (mg GAE / g)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' antioxidant capacity (μg TE/g)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' total starch analysis (g)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' resistant starch (g)
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' in vitro starch digestion rate (%) and glycemic index
timeFrame: up to 8 weeks
measure: Chemical analysis of test and control breads' moisture (baking) loss (%)
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Toros University
state: Yenişehir
Study officials:
affiliation: Head of Toros University Scientific Research Projects
name: Yüksel Özdemir, Prof.
role: PRINCIPAL_INVESTIGATOR
References: