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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966494
Other study ID # 20131004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2013
Est. completion date November 2, 2015

Study information

Verified date July 2021
Source Universidad Autonoma de Queretaro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypertriglyceridemia is a serious condition in the Mexican population and it is considered a major risk factor for cardiovascular disease. Current efforts to prevent dyslipidemia and lipids alteration include the development of functional products as an alternative for the management of hypertriglyceridemia. Common beans (Phaseolus vulgaris L.) are a recognized good source of bioactive compounds, mainly phenolic compounds, total dietary fiber (insoluble and soluble fiber, resistant starch and oligosaccharides), saponins, and phytosterols that exert hypolipidemic effects. In this sense, the development of beans-based food products is an alternative for improving the general health status. In previous work, a beans-oats snack bar formulation was found to be a promising potential functional product. In order to validate those results, the aim of this works was to assess a clinical trial was conducted with Mexican women to assess the effect of daily consumption of the functional product on serum triglycerides and certain plasma proteins involved in lipids metabolism in a clinical trial. The clinical trial was 2 months, randomized parallel study where 32 women with elevated triglycerides were randomized into the treatment group and control group. The Control group received nutritional orientation whereas the treatment group received the orientation and consumed 50 g of the product per day. Fasting blood samples were collected at baseline and the end of the study, obtaining serum and plasma for analysis of lipids profile, glucose, and biomarkers. To determine changes in plasma proteins, a 182 protein Human Obesity Antibody Array was used, and the results were analyzed using a bioinformatic-based analysis from Ingenuity Pathways Analysis (QIAGEN)


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2, 2015
Est. primary completion date July 13, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - No current diagnoses of illnesses. - Triglycerides levels among 150 and 350 mg/dL. - No allergies to common beans and oats. - Not pregnant or lactating. Exclusion Criteria: - If they had current diagnoses of diabetes, hypertension, irritable bowel syndrome, or cancer. - Taking anti-inflammatory drugs. - Fasting glucose >100 mg/dL, total cholesterol >240 mg/dL, LDL C>160 mg/dL. - Reported intolerances to BOSB ingredients.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
BOSB
BOSB consisted on a oats (26 %), common beans (30 %), water and emulsifier-based snack bar, administered daily (50 g/day) during 8 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autonoma de Queretaro

Outcome

Type Measure Description Time frame Safety issue
Primary Triglycerides Significant change 8 weeks
Primary Glucose Significant change 8 weeks
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