The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in glycaemic response (capillary blood glucose)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
REFERENCE: white bread - BGL0 [RP]
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.
干预措施: REFERENCE: white bread - BGL0 [RP] (Other)
TEST: b-glucan enriched bread - BGL2 [IP1]
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.
干预措施: TEST: b-glucan enriched bread - BGL2 [IP1] (Other)
TEST: b-glucan enriched bread - BGL3 [IP2]
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.
干预措施: TEST: b-glucan enriched bread - BGL3 [IP2] (Other)
TEST: b-glucan enriched bread - BGL4 [IP3]
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.
干预措施: TEST: b-glucan enriched bread - BGL4 [IP3] (Other)
结局指标
主要结局
Change in glycaemic response (capillary blood glucose)
时间窗: 2 hours
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)
次要结局
未报告次要终点