NCT06382506

Brief Summary

One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 21, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

February 17, 2024

Last Update Submit

April 21, 2024

Conditions

Keywords

ObesityCeliac DiseaseBlood glucoseFlour Sensitivity

Outcome Measures

Primary Outcomes (1)

  • One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption.

    The effect of loaves of bread with a high glycemic index on blood glucose is well known. The higher the glycemic index, the higher the blood glucose fluctuation. Glycemic index values should be lower than white bread. Consumption of hazelnut flour rich in fatty acids and fiber should show a positive change in blood glucose.

    Within research completion, an average of a month

Secondary Outcomes (1)

  • This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week.

    Within research completion, an average of 1 week

Study Arms (2)

The effect of cornbread consumption blood glucose fluctuations in participants.

EXPERIMENTAL

The bread contained 50 grams of digestible carbohydrates. Participants consumed these loaves of bread when they were hungry. Blood glucose measurements were taken at 0 (fasting),15, 30, 45, 60, 90, and 120 minutes.

Dietary Supplement: Consumption of Cornbread with Hazelnut Bread

The effect of cornbread with hazelnut bread consumption blood glucose fluctuations in participants.

EXPERIMENTAL

The bread contained 50 grams of digestible carbohydrates. Participants consumed these loaves of bread when they were hungry. Blood glucose measurements were taken at 0 (fasting),15, 30, 45, 60, 90, and 120 minutes.

Dietary Supplement: Consumption of Cornbread with Hazelnut Bread

Interventions

Cornbread was added to 15 grams and 30 grams of bread and consumed by the participants. Blood glucose levels were then measured. Obese and normal-weight individuals will be divided into two groups according to their anthropometric measurements.

The effect of cornbread consumption blood glucose fluctuations in participants.The effect of cornbread with hazelnut bread consumption blood glucose fluctuations in participants.

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study group consisted of volunteer individuals aged between 18 and 35 years.
  • The first blood glucose measurement was taken after at least 8 hours of fasting and any of the bread types were given to the participants for consumption.
  • During the measurements, the volunteers were observed to avoid water, coffee, and any food intake and to avoid excessive exercise.

You may not qualify if:

  • Pregnant,
  • lactating women
  • patients with physician-diagnosed chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avrasya University

Trabzon, 61000, Turkey (Türkiye)

Location

Related Publications (1)

  • Cesur F, Uygur B. Can hazelnut flour added to gluten-free corn flour in different amounts cause differences in blood glucose fluctuations? Int J Food Sci Nutr. 2025 Feb;76(1):84-92. doi: 10.1080/09637486.2024.2435841. Epub 2024 Dec 3.

MeSH Terms

Conditions

ObesityCeliac Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2024

First Posted

April 24, 2024

Study Start

March 21, 2024

Primary Completion

April 21, 2024

Study Completion

April 21, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations