The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar

NCT03878576 | Completed

• 1 other identifier: KME/0120-441/2018/4
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of content of barley beta-glucans in bread on postprandial blood sugar will be measured with open-label crossover study. Study will be conducted in Slovenia on 10-12 adult subjects who will test three barley beta-glucan containing bread formulations (food) in comparison with a reference white bread. Objective of the study is to investigate the influence of the content of barley beta-glucan in bread on glycaemic index (incremental area under the curve (IAUC) for the blood glucose response curve for barley beta-glucan containing breads in comparison to reference white bread.

Conditions

Glycemic Index

Keywords

Glycemic Index; glycemic response; bread; barley; beta-glucans; glucose level; continous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Change in glycaemic response (capillary blood glucose)

  Change in incremental area under the curve (IAUC) the blood glucose response curve for barley beta-glucan containing breads (investigational products; IP1-3), in comparison to white bread (reference product; RP)

  2 hours

Other Outcomes (1)

• Glucose level as measured with continuous glucose monitor (CGM)

  up to 3 hours

Study Arms (4)

REFERENCE: white bread - BGL0 [RP]

ACTIVE COMPARATOR

Participants consume a meal of bread BGL0 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

Other: REFERENCE: white bread - BGL0 [RP]

TEST: b-glucan enriched bread - BGL2 [IP1]

EXPERIMENTAL

Participants consume a meal of bread BGL2 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

Other: TEST: b-glucan enriched bread - BGL2 [IP1]

TEST: b-glucan enriched bread - BGL3 [IP2]

EXPERIMENTAL

Participants consume a meal of bread BGL3 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

Other: TEST: b-glucan enriched bread - BGL3 [IP2]

TEST: b-glucan enriched bread - BGL4 [IP3]

EXPERIMENTAL

Participants consume a meal of bread BGL4 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

Other: TEST: b-glucan enriched bread - BGL4 [IP3]

Interventions

REFERENCE: white bread - BGL0 [RP] OTHER

Determination of glycemic response after consumption of BGL0.

REFERENCE: white bread - BGL0 [RP]

TEST: b-glucan enriched bread - BGL2 [IP1] OTHER

Determination of glycemic response after consumption of BGL0.

TEST: b-glucan enriched bread - BGL2 [IP1]

TEST: b-glucan enriched bread - BGL3 [IP2] OTHER

Determination of glycemic response after consumption of BGL0.

TEST: b-glucan enriched bread - BGL3 [IP2]

TEST: b-glucan enriched bread - BGL4 [IP3] OTHER

Determination of glycemic response after consumption of BGL0.

TEST: b-glucan enriched bread - BGL4 [IP3]

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject Informed consent form (ICF) is singed
• Aged above 18 years at the time of the signature of ICF
• No known food allergy or intolerance
• No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
• Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
• Body mass index (BMI) \> 25

You may not qualify if:

• Subject Informed consent form (ICF) is singed
• Aged above 18 years at the time of the signature of ICF
• No known food allergy or intolerance
• No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
• Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
• Body mass index (BMI) \> 25

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• Community Health Centre Ljubljana: collaborator
• Slovenian Research Agency: collaborator
• Valens Int. d.o.o., Slovenija: collaborator

Study Sites (1)

Nutrition Institite

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

I-kappa B Kinase

Intervention Hierarchy (Ancestors)

Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Igor Pravst, PhD

  Institut za nutricionistiko

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: November 26, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)