Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.

NCT ID: NCT05687812

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-12-31

Brief Summary

Cephalaria Syriaca is a common weed in Anatolia and grows wild in wheat fields, with high fat, protein, and dietary fiber content. This study it is aimed to evaluate the effects of lowering the glycemic index of white bread consumed in large quantities in Turkey by adding Cephalaria Syriaca, on healthy, obese, and diabetic individuals.

Detailed Description

Nutrition is essential in the treatment and management of diabetes and obesity, and other accompanying diseases. Consumption of low glycemic index (GI) foods is the primary approach in medical nutrition therapy to ensure glycemic control and long-term satiety. The glycemic index is the rate at which foods raise blood sugar. The GI is determined by comparing the area of increase in blood glucose within 2 hours after consumption and absorption of a test food containing 100 g of digestible carbohydrates to the area of increase in glucose generated by the reference food containing the same amount of carbohydrates (primarily white bread). The GI value of the food taken as a reference is 100, and the reference ranges of foods are ≤55 low, 56-69 moderate, and ≥70 high GI. Annual bread consumption is much higher than the world average in Turkey and is about 400 g/day. It has been determined that 66% of the energy consumed per capita is provided from cereals, 56% of this energy is met from bread, and 50% of the protein in the daily diet is completed from bread.

It has been reported that the GI of white bread is 87 in our country and 70 in other countries. Reducing the GI value of a large amount of food consumed will be a positive step for obesity and diabetes management.

Cephalaria syriaca, common in Anatolia and growing wild in wheat fields, has high oil (~20%), protein (15.5%), dietary fiber (25.5%), and polyphenol content and is an annual weed rich in vitamins and minerals. It is known that the flour obtained from Cephalaria Syricia seed strengthens even the flours with low core quality. For this reason, it is used especially in rural areas to increase dough and bread quality. It is known that dietary fiber, fat, and protein contents in foods lower the GI value. Therefore, Cephalaria Syricia flour added to bread flour is expected to reduce the GI value of bread. A study conducted in 2020 showed that the GI value of regular white bread with 5% Cephalaria Syricia flour added decreased by 17%. Although there are in-vitro studies on the effects of Cephalaria Syricia in the literature, no clinical studies with published results have been found. From this point of view, this study is planned to investigate the effects of 0.2% Cephalaria Syricia flour added to bread (market name: İstanbul Halk Ekmek, Akdeniz Bread) on blood glucose and related hormones levels of individuals with diabetes and obesity and healthy volunteers.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Diabetic group

After 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes.

Group Type: EXPERIMENTAL

Cephalaria Syriaca flour-added bread

Intervention Type: DIETARY_SUPPLEMENT

100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH).

Non-diabetic obese group

After 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes.

Group Type: EXPERIMENTAL

Cephalaria Syriaca flour-added bread

Intervention Type: DIETARY_SUPPLEMENT

100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH).

Non-diabetic and non-obese healthy group

After 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes.

Group Type: EXPERIMENTAL

Cephalaria Syriaca flour-added bread

Intervention Type: DIETARY_SUPPLEMENT

100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH).

Interventions

Cephalaria Syriaca flour-added bread

100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Healthy group (n=20):

• 18-65 years of age, non-obese and non-diabetic healthy individuals
• OGTT is normal
• Body Mass Index (BMI)= 18.5-24.9 kg/m2

Diabetic group (n=20):

• Individuals aged between 18-65 years with Type 2 Diabetes

• Using only metformin
• BMI= 18.5-29.9 kg/m2

Obese group (n=20):

• 18-65 years of age, non-diabetic and obese individuals;

• BMI ≥ 30 kg/m2

Exclusion Criteria

Individuals with

• Smoking
• Use Alcohol
• Pregnant
• Breastfeeding
• Those with chronic diseases (CKD, COPD, Malignancy,..)
• Using food supplements
• Using DPP-4 inhibitors and GLP-1release analog in the treatment of DM
• Professional athlete or excessive physical activity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Fulya Calikoglu

MD, PhD; Academician; Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism

Istanbul, Capa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/342

Identifier Type: -

Identifier Source: org_study_id