Metabolic Syndrome Clinical Trial
Official title:
Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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