Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-05

Study Completion Date

2015-11-02

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)

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Detailed Description

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Conditions

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Hypertriglyceridemia Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BOSB Group

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

Group Type EXPERIMENTAL

BOSB

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

This group corresponded to hypertriglyceridemic women who does not consume BOSB

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BOSB

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

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes