Effects of Bran Size on Glycemic Responses

NCT03314142 | Completed DMC

• 1 other identifier: 1256
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Potential Abnormality of Glucose Tolerance; Appetitive Behavior

Keywords

blood glucose; bran particle size; glucemic index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective appetite ratings

  2 hours

Study Arms (5)

Glucose as reference food

EXPERIMENTAL

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; 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

White bread as reference food

EXPERIMENTAL

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; 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

Bread enriched with coarse wheat bran

EXPERIMENTAL

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; 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

Bread enriched with fine wheat bran

EXPERIMENTAL

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; 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

Bread enriched with fine wheat and carob

EXPERIMENTAL

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; 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

Interventions

Glucose as reference food OTHER

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.

Bread enriched with coarse wheat bran; Bread enriched with fine wheat and carob; Bread enriched with fine wheat bran; Glucose as reference food; White bread as reference food

White bread as reference food OTHER

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.

Bread enriched with coarse wheat bran; Bread enriched with fine wheat and carob; Bread enriched with fine wheat bran; Glucose as reference food; White bread as reference food

Bread enriched with coarse wheat bran OTHER

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.

Bread enriched with coarse wheat bran; Bread enriched with fine wheat and carob; Bread enriched with fine wheat bran; Glucose as reference food; White bread as reference food

Bread enriched with fine wheat bran OTHER

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.

Bread enriched with coarse wheat bran; Bread enriched with fine wheat and carob; Bread enriched with fine wheat bran; Glucose as reference food; White bread as reference food

Bread enriched with fine wheat bran and carob seed flour OTHER

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.

Bread enriched with coarse wheat bran; Bread enriched with fine wheat and carob; Bread enriched with fine wheat bran; Glucose as reference food; White bread as reference food

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead

Study Sites (1)

Agricultural University of Athens

Athens, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Emilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutrition and Metabolism

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 19, 2017
• Study Start: March 30, 2017
• Primary Completion: July 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)