NCT05687812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 8, 2023

Last Update Submit

January 18, 2023

Conditions

Nutrition, Healthy

Keywords

Cephalaria Syriaca, glycemic index, type 2 diabetes, obesity

Outcome Measures

Primary Outcomes (8)

  • Plasma GLP-1 levels changes

    Change in baseline GLP-1 levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma PYY levels changes

    Change in baseline PYY levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma Leptin levels changes

    Change in baseline Leptin levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma Ghrelin levels changes

    Change in baseline Ghrelin levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma IL-6 levels changes

    Change in baseline IL-6 levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma insulin levels changes

    Change in baseline insulin levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma glucose levels changes

    Change in baseline glucose levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

  • Plasma c-peptide levels changes

    Change in baseline c-peptide levels at 2 hours. Measured by plasma samples.

    Through OGTT test completion, an average of 2 hours

Secondary Outcomes (2)

  • Plasma triglyceride levels changes

    Through OGTT test completion, an average of 2 hours

  • Appetite regulation

    Through OGTT test completion, an average of 2 hours

Study Arms (3)

Diabetic group

EXPERIMENTAL

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.

Dietary Supplement: Cephalaria Syriaca flour-added bread

Non-diabetic obese group

EXPERIMENTAL

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.

Dietary Supplement: Cephalaria Syriaca flour-added bread

Non-diabetic and non-obese healthy group

EXPERIMENTAL

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.

Dietary Supplement: Cephalaria Syriaca flour-added bread

Interventions

Cephalaria Syriaca flour-added breadDIETARY_SUPPLEMENT

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

Diabetic groupNon-diabetic and non-obese healthy groupNon-diabetic obese group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy group (n=20):
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Capa, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD; Academician; Principle Investigator

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

TU(1)