NCT06288178

Brief Summary

The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB). Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2022

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

Study Start

First participant enrolled

December 19, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 17, 2024

Last Update Submit

February 24, 2024

Conditions

Keywords

obesityGlycemic indexBlood glucoseCornbreadBuckwheat bread

Outcome Measures

Primary Outcomes (1)

  • One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption.

    The effect of loaves of bread with a high glycemic index on blood sugar is well known. The higher the glycemic index, the higher the blood sugar fluctuation. Glycemic index values should be lower than white bread.

    Within research completion, an average of 4 week

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)

Types of bread

EXPERIMENTAL

The three breads (whole wheat bread, buckwheat bread, and cornmeal bread) contained 30 grams of digestible carbohydrates. Participants consumed these breads when they were hungry. Blood glucose was measured with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes. Anthropometric measurements were measured by BIA method and weight classification (obesity and normal weight) was made.

Dietary Supplement: Bread consumption

Reference bread (White bread)

EXPERIMENTAL

Control group. Blood glucose comparison of all breads was determined according to white bread. The measurement method used was the same as for the other breads.

Dietary Supplement: Bread consumption

Interventions

Bread consumptionDIETARY_SUPPLEMENT

There were four groups: whole wheat (WWB), buckwheat (BWB), corn bread (CB) and reference bread.

Reference bread (White bread)Types of bread

Eligibility Criteria

Age18 Years - 35 Years
Sexall
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.
  • All measurements were taken between 09.00-13.00.
  • 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
  • Medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avrasya University

Trabzon, 61000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

March 1, 2024

Study Start

December 19, 2022

Primary Completion

January 20, 2023

Study Completion

February 20, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations