Healthy ParticipantsNCT06200272
Effect of Carob Molasse Pose Flour and Germ On Glycemic Response and Antioxidant Capacity
A study testing Germ and Carob Molasses Pulp added standard whole wheat breads in people with Healthy Participants, run by Toros University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Germ and Carob Molasses Pulp added standard whole wheat breads
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole-Wheat Bread Enriched With Carob Molasse Pose Flour and Germ On Healthy Volunteers' Glycemic Response and Antioxidant Capacity
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Germ and Carob Molasses Pulp added standard whole wheat breads
- Keywords
- Carob molasses pulp, germ, bread, glycemic load, antioxidant capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Germ and Carob Molasses Pulp added standard whole wheat breadsCombination product
Test bread (bread with soluble pulp added, bread with added germ, and bread with soluble pulp + germ added) containing 50 g carbohydrate, samples taken from all four types of bread were collected for moisture, ash, fiber, protein, fat, digestible carbohydrate, and antioxidant capacity analysis will be performed. This experimental group consists of the group that will eat the test bread.
| Study group | Role | What they receive |
|---|---|---|
| Test group with standard whole wheat breads (Germ and Carob Molasses Pulp added) | Experimental | 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 waste after the production of carob molasses, to the formulation of wheat bread, which has been widely consumed in recent years. Receives: Combination Product: Germ and Carob Molasses Pulp added standard whole wheat breads |
| Control group with standard whole wheat breads | No intervention | control bread (whole wheat bread) made based on a standard recipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole wheat bread and blood glucose level at 0th minute
Participants coming to the laboratory and eating control bread will have their capillary blood glucose measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood glucose level at 0th minute
Participants coming to the laboratory and eating test bread will have their capillary blood glucose measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TAS level at 0th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TAS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TAS level at 0th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TAS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TOS level at 0th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TOS level at 0th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood glucose level at 30th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood glucose level at 30th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TAS level at 30th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TAS level at 30th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TOS level at 30th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TOS level at 30th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood glucose level at 60th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood glucose level at 60th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TAS level at 60th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TAS level at 60th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TOS level at 60th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TOS level at 60th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood glucose level at 120th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood glucose level at 120th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TAS level at 120th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TAS level at 120th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TOS level at 120th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TOS level at 120th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood glucose level at 180th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood glucose level at 180th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TAS level at 180th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TAS level at 180th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread and blood TOS level at 180th minute
Participants coming to the laboratory and eating control bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Whole wheat bread (added CMP and germ) and blood TOS level at 180th minute
Participants coming to the laboratory and eating test bread will have their capillary blood TOS measured with a calibrated glucometer at minute 0.
Measured: One day
Secondary outcomes (19)
Sociodemographic information form of participants eating whole wheat bread and whole wheat bread (added CMP and germ)
It is a form that questions information about the individual's health, education and economic status.
Measured: One day
Determination of food consumption
Food consumption will be taken in order to evaluate differences between individuals that may affect the result. It covers a total of two days, one day before the 1st bread (standard whole wheat bread) and one day before the 2nd bread (test whole wheat bread), and the foods and beverages consumed by the individual are questioned.
Measured: One day
Measurements of weight (kg) and height (cm)
Weight (kg) will be measured by Bioelectrical Impedance Analysis (BIA) body composition analyzer. Height (cm) will be measured using a stadiometer. The stadiometer comprises a rigid vertical backboard and a horizontal headboard running free, perpendicular to the backboard and without cross-play. The top of the head must be in contact with the headboard. After that, body mass index (BMI) will be calculated by using weight and height measurements. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: 1 day
Measurements of Basal Metabolic Rate (kkal)
Basal Metabolic Rate (kkal) will be measured by Bioelectrical Impedance Analysis (BIA) body composition analyzer.
Measured: 1 day
Measurements of Body Fat
Body Fat Mass (kg), Muscle Mass (kg), Visceral fat accumulation will be measured by Bioelectrical Impedance Analysis (BIA) body composition analyzer.
Measured: 1 day
Measurements of Body Fluid
Total Body Fluid Mass (TBW) (L) (0.1 kg and 0.1%), Extracellular Fluid (ECW) (L) (0.1 kg), Intracellular Fluid (ICW) (L) (0.1 kg) will be measured by Bioelectrical Impedance Analysis (BIA) body composition analyzer. Edema wşll be calculated by the ratio of ECW/TBW.
Measured: 1 day
Circumferences measurements
Waist and Hip Ratio can be measured and waist/hip ratio be calculated from participants eating both test and control bread.
Measured: 1 day
Chemical analysis of test and control breads' protein content (%)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of protein content (%) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. Based on the results obtained, the amount of breads containing 50 g digestible carbohydrate will be calculated and produced.The Kjeldahl method will be applied to determine the total amount of nitrogen provided by the food. Protein content (%) is obtained by multiplying the total amount of nitrogen detected by the nitrogen factor determined according to the total organic nitrogen properties within the protein molecules. It is ensured that the test samples to be produced have more protein content than the standard.
Measured: up to 8 weeks
Chemical analysis of test and control breads' moisture content (%)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of moisture content (%) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. Moisture content (%) will be based on the weight difference after drying in the oven at 105ºC until a constant weighing weight is reached. Moisture analysis in bread samples will be carried out after the bread is baked and cooled for 1 hour. The test samples to be produced are expected to contain moisture close to the standard.
Measured: up to 8 weeks
Chemical analysis of test and control breads' specific volume (m3/kg or m3·kg-1)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the determination of specific volume (m3/kg or m3·kg-1) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. The volumes of baked bread samples will be determined according to the rapeseed replacement method. The specific volume values of the bread samples produced are; It will be calculated by dividing the bread volume (cm3) to the bread weight (g). The test samples to be produced are expected to have a specific volume at least as much as that of control bread.
Measured: up to 8 weeks
Chemical analysis of test and control breads' colorimetric assays (EBC)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the determination of colorimetric assays (EBC) will be determined via analyses that will be carried at our university Food Chemistry Laboratory.It will be carried out on the crust parts of the bread using the HunterLab brand hand-held color measuring device. L*, chroma (C), hue (h) values will be determined based on the CIE L*Ch* color system, which is one of the color definition models determined by the International Institute of Illumination (CIE). The test samples to be produced are expected to be close in color to control bread.
Measured: up to 8 weeks
Chemical analysis of test and control breads' lipid content (%)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of lipid content (%) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. It will be carried out using the Soxhlet method. Approximately 4 g of bread samples will be weighed into a cellulose cartridge, covered with cotton and placed in the Soxhlet apparatus. At the end of the extraction using petroleum ether, the ether in the balloons will be evaporated and the oil content in the sample will be calculated. The test samples to be produced are expected to contain more unsaturated fatty acids than the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' ash content (%)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of ash content (%) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. The samples will be weighed in a porcelain crucible that has previously been brought to a constant weight, and will be burned in a muffle furnace (Elektro-mag M1813, Turkey) at 550±5ºC until the residue becomes almost white in color. The % ash amount of the breads will be calculated by proportioning the sample mass remaining in the crucibles at the end of the burning process to the initial sample mass. The test samples to be produced are expected to contain more mineral substances than the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' total phenolic content (mg GAE / g)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of total phenolic content (mg GAE / g) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. It will be determined by the Folin-Ciocalteau method. Sample extracts and Folin-Ciocalteau reagent prepared for this purpose will be used. 0.1 ml of extract will be mixed with 0.5 ml of Folin-Ciocalteu reagent (reagent: water mixture 1:10 v/v) and kept in the dark for 5 minutes. Then 0.4mL of saturated sodium carbonate solution and 4mL of pure water will be added. The mixture will be kept in the dark at room conditions for approximately 1 hour and the absorbance will be measured in a UV-VIS spectrophotometer at 760 nm. The result will be evaluated by calculating phenolic substance contents based on gallic acid equivalent. The test samples to be produced are expected to contain more polyphenols than the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' antioxidant capacity (μg TE/g)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of antioxidant capacity (μg TE/g) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. 5 g sample will be taken from powdered defatted bread samples and mixed with 50 mL 80:20 methanol:water (v:v) for 30 minutes and then centrifuged at 4500 g for 15 minutes. 100 µL of the extracts will be taken into a cuvette and 3900 µL of DPPH (1,1-diphenyl-2-picrylhydrazyl radical) solution (2.36 mg/100 Mlmethanol) will be added and kept in the dark for 30 minutes. Absorbance measurements will be made on a spectrophotometer at 515 nm against the blank. Trolox calibration will be used to determine the activity value. The antioxidant value of the extracts will be stated as mMTrolox equivalent per kg. The test samples to be produced are expected to show more antioxidant properties than the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' total starch analysis (g)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of total starch analysis (g) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. Total starch in the developed bread will be determined enzymatically according to the modified method of Goni et al. (1997). The test samples to be produced are expected to contain more starch than the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' resistant starch (g)
Chemical analysis were developed and the amount of both test and control bread containing 50 g carbohydrate and the amount of resistant starch analysis (g) will be determined via analyses that will be carried at our university Food Chemistry Laboratory. Enzyme resistant starch will be determined in the samples using the "Megazyme resistant starch kit". For example, starch will be digested and converted into glucose with the help of α-amylase and amyloglucosidase enzymes. After adding ethyl alcohol to the samples, they will be centrifuged and the precipitated enzyme-resistant starch will be pelletized. After being dissolved with potassium hydroxide, the dissolved starch will turn into amyloglucose and glucose. Thus, the glucose formed will be determined spectrophotometrically. The test samples to be produced are expected to contain more resistant starch than the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' in vitro starch digestion rate (%) and glycemic index
Starch digestion rate for breads will be expressed as the percentage of total starch hydrolyzed at incubation time intervals of 30 minutes, 60 minutes, 90 minutes and 120 minutes. The Hydrolysis Index (HI) will be derived from the ratio between the areas under the hydrolysis curve of the developed product and the reference sample (control wheat bread). From the obtained hydrolysis index, the estimated glycemic index (GI) will be calculated using the equation established by Goni et al. (1997). It is expected that the test samples to be produced will have a slower starch digestion rate and a lower glycemic index compared to the control.
Measured: up to 8 weeks
Chemical analysis of test and control breads' moisture (baking) loss (%)
The moisture (baking) loss (%) value of bread samples will be based on the weight difference of the fixed dough weight (45 g) and the final product, baked bread samples. Baking loss (%) will be calculated with the formula = ((Dough weight-Bread weight)/Dough weight))*100. It is expected that the test samples to be produced will have a baking loss close to that of control bread.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Parlak, Toros University
- Investigators
- Yüksel Özdemir, Prof., Principal investigator, Head of Toros University Scientific Research Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200272
- Sponsor's protocol ID
- EDA-YL-EBRAR-TOROS-001
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tusat E, Parlak E, Yildirim G, Oztop K, Gulsen B, Ozdemir Y, Uysal Y. Impact of White Bread Fortified With Carob Molasses Pulp Flour and Wheat Germ on Glycemic Response and Antioxidant Capacity in Healthy Subjects. Food Sci Nutr. 2025 Dec 4;13(12):e71046. doi: 10.1002/fsn3.71046. eCollection 2025 Dec.
PubMed 41356220
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-Wheat Bread Enriched With Carob Molasse Pose Flour and Germ On Healthy Volunteers' Glycemic Response and Antioxidant Capacity
- ClinicalTrials.gov ID
- NCT06200272
- Acronym / sponsor ID
- EDA-YL-EBRAR-TOROS-001
- Conditions
- Healthy Participants
- Keywords
- Carob molasses pulp, germ, bread, glycemic load, antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group with standard whole wheat breads (Germ and Carob Molasses Pulp added) | Experimental | Combination Product: Germ and Carob Molasses Pulp added standard whole wheat breadsBread 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 waste after the production of carob molasses, to the formulation of wheat bread, which has been widely consumed in recent years. |
| Control group with standard whole wheat breads | No intervention | –control bread (whole wheat bread) made based on a standard recipe |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Germ and Carob Molasses Pulp added standard whole wheat breadsTest bread (bread with soluble pulp added, bread with added germ, and bread with soluble pulp + germ added) containing 50 g carbohydrate, samples taken from all four types of bread were collected for moisture, ash, fiber, protein, fat, digestible carbohydrate, and antioxidant capacity analysis will be performed. This experimental group consists of the group that will eat the test bread. | Combination product | Test group with standard whole wheat breads (Germ and Carob Molasses Pulp added) |
Primary outcome
Whole wheat bread and blood glucose level at 0th minute
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 and blood TOS level at 0th minute
Time frame: 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 0th minute
Time frame: 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
Time frame: 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 30th minute
Time frame: 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 30th minute
Time frame: 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 30th minute
Time frame: 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
Time frame: 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 30th minute
Time frame: 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
Time frame: 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
Time frame: 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 60th minute
Time frame: 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
Time frame: 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 60th minute
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 120th minute
Time frame: 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
Time frame: 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 180th minute
Time frame: 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
Time frame: 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 180th minute
Time frame: 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
Time frame: 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
Time frame: 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.
19 secondary outcomes
Sociodemographic information form of participants eating whole wheat bread and whole wheat bread (added CMP and germ)
Time frame: One day
Determination of food consumption
Time frame: One day
Measurements of weight (kg) and height (cm)
Time frame: 1 day
Measurements of Basal Metabolic Rate (kkal)
Time frame: 1 day
Measurements of Body Fat
Time frame: 1 day
Measurements of Body Fluid
Time frame: 1 day
Circumferences measurements
Time frame: 1 day
Chemical analysis of test and control breads' protein content (%)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' moisture content (%)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' specific volume (m3/kg or m3·kg-1)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' colorimetric assays (EBC)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' lipid content (%)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' ash content (%)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' total phenolic content (mg GAE / g)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' antioxidant capacity (μg TE/g)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' total starch analysis (g)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' resistant starch (g)
Time frame: up to 8 weeks
Chemical analysis of test and control breads' in vitro starch digestion rate (%) and glycemic index
Time frame: up to 8 weeks
Chemical analysis of test and control breads' moisture (baking) loss (%)
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 41356220Tusat E, Parlak E, Yildirim G, Oztop K, Gulsen B, Ozdemir Y, Uysal Y. Impact of White Bread Fortified With Carob Molasses Pulp Flour and Wheat Germ on Glycemic Response and Antioxidant Capacity in Healthy Subjects. Food Sci Nutr. 2025 Dec 4;13(12):e71046. doi: 10.1002/fsn3.71046. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yüksel Özdemir, Prof. principal investigator
Head of Toros University Scientific Research Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Germ and Carob Molasses Pulp added standard whole wheat breads in people with Healthy Participants, run by Toros University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole wheat bread and blood glucose level at 0th minute (time frame: One day). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.