Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

Study Overview
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Brief Summary
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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)

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

Conditions
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Hypertriglyceridemia, Obesity

Intervention / Treatment
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* Dietary Supplement: BOSB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOSB Group<br>This group consumed a common beans and oats snack bar (BOSB) for 8 weeks. | Dietary Supplement: BOSB<br>* BOSB consisted on a oats (26 %), common beans (30 %), water and emulsifier-based snack bar, administered daily (50 g/day) during 8 weeks.<br>|
| No Intervention: Control Group<br>This group corresponded to hypertriglyceridemic women who does not consume BOSB | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | Significant change | 8 weeks | 
| Glucose | Significant change | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common beans, Oats, Proteomic Analysis, Phenolic compounds, Dietary Fiber