Black Barley Study - Barley to Support Food and Drink Innovation (RI-B7-3)

NCT ID: NCT06673212

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-27
• Study Completion Date: 2024-06-28

Brief Summary

Sustained postprandial hyperglycaemia is an independent risk factor for cardiovascular complications and death. Intensive glucose control is the predominant factor to prevent the development of chronic complications in Type 2 Diabetes Mellitus (T2DM). The investigators have shown that phytochemical-rich extracts (in this case anthocyanins and their derivatives) can attenuate glucose response and there is also strong evidence for the role of fibre. Here a selected barley line (rich in anthocyanins and (1,3;1,4)-β-glucan) will be compared to a control barley and control wheat in an acute human dietary intervention (with n=15 healthy volunteers) to explore the potential to modulate postprandial glycaemia and insulinaenemia. An additional secondary outcome will include metabolomics analysis of the blood plasma and urine to detect differences in bioactive compounds including phytochemical metabolites. This will help ensure that barley lines being bred for human food can also deliver benefits for health.

Detailed Description

Barley is an important Scottish crop in terms of contributing to the distilling industry but underutilised as a healthy (and potentially sustainable food). The investigators have shown (unpublished data) that barleys entering the food supply chain are not bred for food but are often grain destined for distilling and not rich is components of value for human nutrition, for example (1,3;1,4)-β-glucan, micronutrient vitamins and minerals as well as bioactive phytochemicals associated with reduction of non-communicable diseases such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD).

Current research is exploring the potential of specifically bred food barleys to require less inputs in terms of nutrients and pesticides and grow on more marginal lands providing farmers with a crop harvested at a different time of year, mitigating against unpredictable weather and a changing climate. It is important that these barleys also deliver benefits to human health. There are established health claims with regard to the lipid lowering effect of (1,3;1,4)-β-glucan and phytochemical-rich barleys could also potentially reduce blood glucose, an important factor leading to metabolic deregulation and subsequent disease development. This would meet the needs of people choosing a healthy lifestyle, as well as those living with or at risk of T2DM. From the food collections being developed at the James Hutton Institute, an accession (high in (1,3;1,4)-β-glucan and phytochemicals) will be selected and tested in an acute dietary intervention to determine if postprandial blood glucose levels are reduced. This will be compared to control barley and wheat products.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Wheat Bread

Control Wheat Bread will be prepared to the same formulation as white wheat bread.

Group Type: ACTIVE_COMPARATOR

Control Wheat Bread

Intervention Type: OTHER

Ingredients: Wheat Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar

Berneray Bere barley bread

Berneray Bere barley bread will be prepared to a formulation as for the white wheat bread, but the wheat flour will be replaced with Berneray Bere barley flour.

Group Type: EXPERIMENTAL

Berneray Bere barley bread

Intervention Type: OTHER

Ingredients: Berneray Bere Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar

Black Barley bread

Black Barley bread will be prepared to a formulation as for the white wheat bread, but the wheat flour will be replaced with Black Barley flour.

Group Type: EXPERIMENTAL

Black Barley bread

Intervention Type: OTHER

Ingredients: Black Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar

Interventions

Control Wheat Bread

Ingredients: Wheat Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar

Intervention Type: OTHER

Berneray Bere barley bread

Ingredients: Berneray Bere Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar

Intervention Type: OTHER

Black Barley bread

Ingredients: Black Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Apparently healthy male and female subjects with Diabetes Risk Score ≥ 7 points

Exclusion Criteria

• Type 1 diabetes
• Type 2 diabetes controlled with medication
• Coeliac Disease
• Eating disorders (anorexia, bulimia, binge eating or night eating syndrome)
• Food allergies/intolerances
• Any significant health issues
• Breastfeeding/ Pregnancy
• Addiction to any substances
• Are unable to give written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Russell

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

University of Aberdeen, The Rowett Institute

Aberdeen, , United Kingdom

Countries

United Kingdom

Other Identifiers

ROW_2022_001

Identifier Type: -

Identifier Source: org_study_id