NCT06565676

Brief Summary

The aim of the study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. In the study, all volunteer participants will be randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four consecutive days and their blood glucose levels will be measured at certain minutes. There are no studies in the literature investigating the effect of whey powder added to bread on blood glucose.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 8, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 8, 2024

Last Update Submit

August 22, 2024

Conditions

Keywords

Whey proteinBlood glucoseEnriched foodSustainable nutrition

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose response

    Postprandial glucose response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes. Higher values represent a worse outcome.

    Two hours postprandial period (from fasting to 120 minutes after the test breakfast)

Study Arms (4)

White Bread

EXPERIMENTAL

Participants will have their fasting blood glucose measured immediately before the meal containing the white flour test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes.

Dietary Supplement: Bread with whey protein powder added

White Bread with Whey Powder

EXPERIMENTAL

Participants will have their fasting blood glucose measured immediately before the meal containing the white flour with added whey powder test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes.

Dietary Supplement: Bread with whey protein powder added

Wheat Bread

EXPERIMENTAL

Participants will have their fasting blood glucose measured immediately before the meal containing the wheat flour test bread will then be asked to consume the entire test bread with their breakfast meal within 15 minutes.

Dietary Supplement: Bread with whey protein powder added

Wheat Bread with Whey Powder

EXPERIMENTAL

Participants will have their fasting blood glucose measured immediately before the meal containing the wheat flour with added whey powder test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes.

Dietary Supplement: Bread with whey protein powder added

Interventions

Volunteer participants will consume bread with and without whey powder added and its effect on blood sugar will be examined.

Wheat BreadWheat Bread with Whey PowderWhite BreadWhite Bread with Whey Powder

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having a normal BMI (18.5-25.0 kg/m2),
  • being between 19-35 years of age,
  • not having any chronic disease,
  • not taking any medication, multivitamin or mineral supplements,
  • not drinking alcohol or smoking,
  • not engaging in heavy physical activity,
  • not being pregnant or lactating.

You may not qualify if:

  • having very low and high BMI (\<18.5 kg/m2 and \>25.0 kg/m2),
  • being younger than 19 years and older than 35 years,
  • having any chronic disease,
  • taking medication, multivitamin or mineral supplements,
  • alcohol and smoking, heavy physical activity,
  • being pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Bread

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Aslı ONUR CANAYDIN, MsC

    Erciyes Üniversitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aslı ONUR CANAYDIN, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The order of bread types to be consumed by the participants will be determined by a person who is not a researcher in the study by simple randomization method using Microsoft Excel program. A researcher who does not interact with the participants will provide the participants with breakfast containing the test breads every day. Due to the difference in bread types, the comparison of breads will be double-blind. An investigator who does not know the type of bread consumed will be assigned for glucose measurement and will be blinded to the assigned bread.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: All volunteer participants were randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 22, 2024

Study Start

August 20, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations