Effect of Carob Molasse Pose Flour and Germ On Glycemic Response and Antioxidant Capacity

NCT06200272 | Completed

• 1 other identifier: EDA-YL-EBRAR-TOROS-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Carob molasses pulp; germ; bread; glycemic load; antioxidant capacity

Outcome Measures

Primary Outcomes (30)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  One day

Secondary Outcomes (19)

• 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 weight (kg) and height (cm)

  1 day

• Measurements of Basal Metabolic Rate (kkal)

  1 day

• Measurements of Body Fat

  1 day

Study Arms (2)

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.

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

Interventions

Germ and Carob Molasses Pulp added standard whole wheat breads COMBINATION_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.

Test group with standard whole wheat breads (Germ and Carob Molasses Pulp added)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Toros University

Mersin, Yenişehir, 33140, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41356220 DERIVED

Study Officials

• Yüksel Özdemir, Prof.

  Head of Toros University Scientific Research Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 10, 2024
• Study Start: December 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)