Effects of Bran Size on Glycemic Responses

Not Applicable

Completed

• Conditions: Appetitive Behavior; Potential Abnormality of Glucose Tolerance
• Interventions: Other: Glucose as reference food; Other: White bread as reference food; Other: Bread enriched with coarse wheat bran; Other: Bread enriched with fine wheat bran; Other: Bread enriched with fine wheat bran and carob seed flour

• Registration Number: NCT03314142
• Lead Sponsor: Agricultural University of Athens

Brief Summary

This study investigated the effects of bran's particle size on glycemic responses

Detailed Description

This study aimed at 1. to determine the GI and GL of three breads and 2. to investigate the effects of bran's particle size on postprandial glycemic response in healthy subjects.

Study Timeline

• Study Start: 2017-03-30
• Primary Completion: 2017-07-30
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-15
• Last Update Submitted: 2017-10-18
• Study First Posted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy, non-smoking, non-diabetic men and women, individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Exclusion Criteria

• severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
• gastrointestinal disorders
• pregnancy
• lactation
• competitive sports
• alcohol or drug dependency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose as reference food	Glucose as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Glucose as reference food	Bread enriched with fine wheat bran and carob seed flour	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
White bread as reference food	Glucose as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
White bread as reference food	Bread enriched with fine wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat bran	Glucose as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Glucose as reference food	White bread as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Glucose as reference food	Bread enriched with fine wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat bran	Bread enriched with fine wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Glucose as reference food	Bread enriched with coarse wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with coarse wheat bran	Glucose as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with coarse wheat bran	Bread enriched with coarse wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat bran	Bread enriched with fine wheat bran and carob seed flour	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
White bread as reference food	Bread enriched with fine wheat bran and carob seed flour	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with coarse wheat bran	Bread enriched with fine wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with coarse wheat bran	Bread enriched with fine wheat bran and carob seed flour	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat bran	Bread enriched with coarse wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
White bread as reference food	White bread as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
White bread as reference food	Bread enriched with coarse wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with coarse wheat bran	White bread as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat bran	White bread as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat and carob	Bread enriched with fine wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat and carob	Bread enriched with fine wheat bran and carob seed flour	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat and carob	Glucose as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat and carob	Bread enriched with coarse wheat bran	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Bread enriched with fine wheat and carob	White bread as reference food	Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Primary Outcome Measures

Name	Time	Method
Capillary blood glucose responses	2 hours	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test.

Secondary Outcome Measures

Name	Time	Method
Subjective appetite ratings	2 hours	Useful change in subjective appetite using visual analogue scales (VAS, 100 mm, given in the form of booklet, one scale per page) before and 2hr after consumption of four different bread types.

Trial Locations

Locations (1)

Agricultural University of Athens; 🇬🇷 Athens, Greece