Effects of Bran Size on Glycemic Responses

Study Overview
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Brief Summary
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This study investigated the effects of bran's particle size on glycemic responses

Detailed Description
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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.

Official Title
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Short-term Effects of Bran Size on Glycemic Responses in Normal Weight Healthy Adults

Conditions
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Potential Abnormality of Glucose Tolerance, Appetitive Behavior

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose as reference food<br>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. | Other: Glucose as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: White bread as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Bread enriched with coarse wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran and carob seed flour<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>|
| Experimental: White bread as reference food<br>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. | Other: Glucose as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: White bread as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Bread enriched with coarse wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran and carob seed flour<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>|
| Experimental: Bread enriched with coarse wheat bran<br>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. | Other: Glucose as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: White bread as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Bread enriched with coarse wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran and carob seed flour<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>|
| Experimental: Bread enriched with fine wheat bran<br>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. | Other: Glucose as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: White bread as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Bread enriched with coarse wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran and carob seed flour<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>|
| Experimental: Bread enriched with fine wheat and carob<br>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. | Other: Glucose as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: White bread as reference food<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Bread enriched with coarse wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>Other: Bread enriched with fine wheat bran and carob seed flour<br>* Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary blood glucose responses | Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood glucose, bran particle size, glucemic index