Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

Obesity Clinical Trial

Official title:

Effect of the Consumption of a Common Bean (Phaseolus Vulgaris L.) and Oats Snack Bar on the Proteomic Profile of Human Mononuclear Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966494
• Other study ID #: 20131004
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Obesity

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