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Completed

NCT Number: NCT06673212

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

About this study

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 The investigators have shown (unpublished data) that barleys entering the food supply chain are not bred for food but are often grain destined for distilling and not rich is components of value for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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Wheat Bread

Other

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

Berneray Bere barley bread

Other

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

Black Barley bread

Other

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

Primary outcomes

  1. Postprandial blood glucose levels

    Time frame: 5 hours

    Modulation of postprandial blood glucose levels after acute consumption of the Black barley, Bere barley and the Wheat breads.

  2. Postprandial insulin levels

    Time frame: 5 hours

    Modulation of postprandial insulin levels after acute consumption of the Black barley, Bere barley and the Wheat breads.

Secondary outcomes

  1. Concentration of phytochemical metabolites in the systemic circulation

    Time frame: 5 hours

    Changes in phytochemical metabolites after acute consumption of the Black barley, Bere barley and the Wheat breads.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

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

Acronym: BB

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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