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Completed

NCT Number: NCT02867215

Barley Bread and Metabolic Disease

The aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.

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Key information

Age range

20 year–53 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Generally, diet can be improved in order to lower diet-related diseases risk. However, the increasing prevalence rates of diet-related diseases indicate that, in practice, people's diet does not follow the recommendations. The intake of whole flour foods is consistently associated with reduced risk of type 2 diabetes and cardiovascular diseases in epidemiological studies, although the mechanisms of this association are unclear. Here the aim is to compare the metabolic effects and mineral status of consumption of diet containing wholemeal barley bread versus whole meal wheat bread in healthy subjects.

The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants was included in the study. In one period subjects received WBB bread; in the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants incorporated this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood was drawn and urine collected and stored for later analysis.

The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Like and tolerate wheat/ barley bread products.
  • Age: 20 - 53 years
  • Body mass index (BMI): 23 - 30 kg/m2
  • Weight stable (<3 kg weight change during the last 6 months)
  • Apparently healthy
  • Informed consent signed
  • Freezer capacity for 1 week bread provision
  • Can attend all visits required for the study

Exclusion criteria

  • Wheat/gluten or barley intolerance
  • Smoking on a daily basis
  • Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
  • Diagnosed with any form of diabetes or cardiovascular disease
  • Reported chronic gastrointestinal disorders
  • Taking dietary supplements during or one month prior to the study
  • Lack of cooperation and adherence to the protocol
  • Use of prescription medication will be evaluated on an individual basis
  • Blood donation within 3 months prior to study start or during the study
  • Participation in other clinical trials

Treatment and study plan

Barley Bread

Other

120g barley bread per day for 3 weeks.

Wheat bread

Other

120g wheat bread per day for 3 weeks.

Primary outcomes

  1. LDL-c levels evaluated by analysis of fasting blood samples

    Time frame: 8-9 weeks

    Evaluated by analysis of fasting blood samples

  2. Glucose levels evaluated by analysis of fasting blood samples

    Time frame: 8-9 weeks

    Evaluated by analysis of fasting blood samples

  3. Insulin levels evaluated by analysis of fasting blood samples

    Time frame: 8-9 weeks

    Evaluated by analysis of fasting blood samples

Secondary outcomes

  1. Mineral status

    Time frame: 8-9 weeks

    Evaluation depends on the mineral. Either by Atom absorption, ICP-MS or spectrometry

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects

Acronym: Barleybread

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2016
Registry last updated
Aug 15, 2016

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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