Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

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

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 Overview

• Status: Completed
• Conditions: Obesity; Hypertriglyceridemia
• Intervention / Treatment: Dietary supplement: BOSB

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOSB Group; This group consumed a common beans and oats snack bar (BOSB) for 8 weeks.	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.
No Intervention: Control Group; This group corresponded to hypertriglyceridemic women who does not consume BOSB

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Autónoma de Querétaro
• Investigators: Principal Investigator: Guadalupe Loarca-Piña, Ph. D., Universidad Autónoma de Querétaro

Publications and helpful links

General Publications

• Ramirez-Jimenez AK, Luzardo-Ocampo I, Cuellar-Nunez ML, Anaya-Loyola MA, Leon-Galvan MF, Loarca-Pina G. Daily Intake of a Phaseolus vulgaris L. Snack Bar Attenuates Hypertriglyceridemia and Improves Lipid Metabolism-Associated Plasma Proteins in Mexican Women: A Randomized Clinical Trial. Front Nutr. 2022 Jun 3;9:890136. doi: 10.3389/fnut.2022.890136. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2013
• Primary Completion (Actual): July 13, 2015
• Study Completion (Actual): November 2, 2015

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Dietary Fiber; Oats; Proteomic Analysis; Phenolic compounds; Common beans
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: 20131004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon reasonable request
• IPD Sharing Time Frame: 10 years
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No