Skip to main content
Clinical Trials/NCT04966494
NCT04966494CompletedNot Applicable

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

Universidad Autonoma de Queretaro0 sites100 target enrollmentStarted: October 5, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Primary Endpoint
Triglycerides

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

BOSB Group

Experimental

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

Intervention: BOSB (Dietary Supplement)

Control Group

No Intervention

This group corresponded to hypertriglyceridemic women who does not consume BOSB

Outcomes

Primary Outcomes

Triglycerides

Time Frame: 8 weeks

Significant change

Glucose

Time Frame: 8 weeks

Significant change

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ivan Luzardo-Ocampo

Associate Researcher

Universidad Autonoma de Queretaro

Similar Trials

Impact of Beans and Oats Snack Bar on... | Clinical Trial