Clinical trial NCT05687812: Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.
Official title: Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Keywords: Cephalaria Syriaca, glycemic index, type 2 diabetes, obesity
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Plasma GLP-1 levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma PYY levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma Leptin levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma Ghrelin levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma IL-6 levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma insulin levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma glucose levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Plasma c-peptide levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
Secondary outcomes:
measure: Plasma triglyceride levels changes
timeFrame: Through OGTT test completion, an average of 2 hours
measure: Appetite regulation
timeFrame: Through OGTT test completion, an average of 2 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism
state: Capa
Study officials:
References: