NCT04749498

Brief Summary

This study aimed to compare the postprandial effects of ß-glucan derived from oats bread (OB) and barley bread (BB) on appetite and glycemia. A randomized, double-blind, crossover trial included 20 healthy individuals. All participants consumed BB, white bread (WB), and whole wheat bread (WWB) with a standard breakfast and then were served an ad libitum lunch on four different days. A visual analog scale (VAS) was used to assess appetite before breakfast and at 15, 30, 60, 90, 120, 150, and 180 minutes after breakfast. Blood glucose levels were measured at 0, 15, 30, 45, 60, 90, and 120 minutes. Postprandial appetite and glucose responses were quantified as the incremental area under the curve (iAUC) calculated according to the trapezoidal rule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable healthy

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

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 6, 2021

Last Update Submit

February 11, 2021

Conditions

Keywords

appetitebarleyβ-glucanbreadglucoseoatsfood intake

Outcome Measures

Primary Outcomes (3)

  • Postprandial appetite response

    The separate visual analog scale factors like hunger, fullness, desiring for eat, and prospective food consumption were combined to produce an additional measure termed 'composite appetite score'. This average appetite score was computed for 0, 15, 30, 60, 90, 120, 150, and 180 minutes using the following equation: \[(hunger + desire to eat + prospective food consumption + (100 - fullness)\]/4 Total scale score changes in a range of 0-100. Higher values represent a worse outcome. Postprandial apetite response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using composite appetite scores at time points 0, 15, 30, 60, 90, 120, 150, and 180 minutes. Higher values represent a worse outcome.

    Three hours postprandial period (from fasting to 180 minutes after the test breakfast)

  • 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)

  • Subsequent energy consumption

    Energy intake at ad libitum lunch was calculated.

    Three hours after consuming the test breakfast (at 180 minutes)

Secondary Outcomes (5)

  • Visual appeal of test bread

    Immediately after consuming test meal (at 15 minutes)

  • Smell of test bread

    Immediately after consuming test meal (at 15 minutes)

  • Taste of test bread

    Immediately after consuming test meal (at 15 minutes)

  • Aftertaste of test bread

    Immediately after consuming test meal (at 15 minutes)

  • Palatability of test bread

    Immediately after consuming test meal (at 15 minutes)

Study Arms (4)

White Bread

ACTIVE COMPARATOR

White bread with a standard test breakfast

Other: White Bread

Whole Wheat Bread

ACTIVE COMPARATOR

Whole wheat bread with a standard test breakfast

Other: Whole Wheat Bread

Barley Bread

EXPERIMENTAL

Barley bread with a standard test breakfast

Other: Barley Bread

Oat Bread

EXPERIMENTAL

Oat bread with a standard test breakfast

Other: Oat Bread

Interventions

Test breakfast with white bread was served after 12-hours of fasting and participants were asked to consume the meal in full, within 15 minutes.

White Bread

In a crossover design, this bread was served with a standard breakfast to compare other breads.

Whole Wheat Bread

In a crossover design, this bread was served with a standard breakfast to compare other breads.

Barley Bread

In a crossover design, this bread was served with a standard breakfast to compare other breads.

Oat Bread

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Normal-weight (BMI 18.5-25 kg/m2)
  • years
  • Having a \<3.5 score on the Dutch Eating Behavior Questionnaire (considered as unrestrictive eating behavior)

You may not qualify if:

  • Applying an energy-restricted diet in the last three months
  • Having a change in body weight \>5 kg in the last three months
  • Vegans
  • Having any chronic diseases such as diabetes, hypertension, etc.
  • Physician-diagnosed medications or conditions that influence metabolism
  • Having fasting glucose \>100 mg/dl
  • Smoking
  • Exercising heavily
  • Having chewing/swallowing difficulties or sensitivity/allergies to any food to be used in the study
  • Lack of appetite
  • Pregnant and lactating women
  • Skipping breakfast meals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Health Sciences

Kayseri, Kayseri̇, 38039, Turkey (Türkiye)

Location

Related Publications (1)

  • Caferoglu Z, Aytekin Sahin G, Gonulalan Z, Hatipoglu N. Effects of whole-grain barley and oat beta-glucans on postprandial glycemia and appetite: a randomized controlled crossover trial. Food Funct. 2022 Oct 3;13(19):10225-10234. doi: 10.1039/d2fo01717b.

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Zeynep Caferoglu, PhD

    Erciyes University Faculty of Health Sciences 38039 Kayseri / Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 11, 2021

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

February 1, 2021

Last Updated

February 15, 2021

Record last verified: 2021-02

Locations