The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar (ARRS-bGL-01)

Nutrition Institute, Slovenia

Status: Completed

Conditions: Glycemic Index

Treatments: Other: REFERENCE: white bread - BGL0 [RP]; Other: TEST: b-glucan enriched bread - BGL3 [IP2]; Other: TEST: b-glucan enriched bread - BGL2 [IP1]; Other: TEST: b-glucan enriched bread - BGL4 [IP3]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03878576

KME/0120-441/2018/4

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

REFERENCE: white bread - BGL0 [RP]

Active Comparator group

Description:

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.

Treatment:

Other: REFERENCE: white bread - BGL0 [RP]

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

Experimental group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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