Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

NCT04966494 | Completed

• 1 other identifier: 20131004
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Hypertriglyceridemia; Obesity

Keywords

Common beans; Oats; Proteomic Analysis; Phenolic compounds; Dietary Fiber

Outcome Measures

Primary Outcomes (2)

• Triglycerides

  Significant change

  8 weeks

• Glucose

  Significant change

  8 weeks

Study Arms (2)

BOSB Group

EXPERIMENTAL

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

Dietary Supplement: BOSB

Control Group

NO INTERVENTION

This group corresponded to hypertriglyceridemic women who does not consume BOSB

Interventions

BOSB 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.

BOSB Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No current diagnoses of illnesses.
• Triglycerides levels among 150 and 350 mg/dL.
• No allergies to common beans and oats.
• Not pregnant or lactating.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Queretaro: lead

Related Publications (1)

• 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.

  PMID: 35719139 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia; Obesity

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guadalupe Loarca-Piña, Ph. D.

  Universidad Autonoma de Queretaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 19, 2021
• Study Start: October 5, 2013
• Primary Completion: July 13, 2015
• Study Completion: November 2, 2015
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: 10 years