Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

Not Applicable

Completed

• Conditions: Hypertriglyceridemia; Obesity
• Interventions: Dietary Supplement: BOSB

• Registration Number: NCT04966494
• Lead Sponsor: Universidad Autonoma de Queretaro

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-05
• Primary Completion: 2015-07-13
• Study Completion: 2015-11-02
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BOSB Group	BOSB	This group consumed a common beans and oats snack bar (BOSB) for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Triglycerides	8 weeks	Significant change
Glucose	8 weeks	Significant change