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

U

University of Aberdeen

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Other: Control Wheat Bread
Other: Berneray Bere barley bread
Other: Black Barley bread

Study type

Interventional

Funder types

Other

Identifiers

NCT06673212
ROW_2022_001

Details and patient eligibility

About

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.

Full 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 The investigators have shown (unpublished data) that barleys entering the food supply chain are not bred for food but are often grain destined for distilling and not rich is components of value for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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

11 participants in 3 patient groups

Control Wheat Bread
Active Comparator group
Description:
Control Wheat Bread will be prepared to the same formulation as white wheat bread.
Treatment:
Other: Control Wheat Bread
Berneray Bere barley bread
Experimental group
Description:
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.
Treatment:
Other: Berneray Bere barley bread
Black Barley bread
Experimental group
Description:
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.
Treatment:
Other: Black Barley bread

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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