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

NCT06673212 | Completed DMC

• 1 other identifier: ROW_2022_001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Postprandial blood glucose levels

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

  5 hours

• Postprandial insulin levels

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

  5 hours

Secondary Outcomes (1)

• Concentration of phytochemical metabolites in the systemic circulation

  5 hours

Study Arms (3)

Control Wheat Bread

ACTIVE COMPARATOR

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

Other: Control Wheat Bread

Berneray Bere barley bread

EXPERIMENTAL

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.

Other: Berneray Bere barley bread

Black Barley bread

EXPERIMENTAL

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.

Other: Black Barley bread

Interventions

Control Wheat Bread OTHER

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

Control Wheat Bread

Berneray Bere barley bread OTHER

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

Berneray Bere barley bread

Black Barley bread OTHER

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

Black Barley bread

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wendy Russell

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: July 27, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 28, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)