Clinical trial NCT04966494: Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women
Official title: Effect of the Consumption of a Common Bean (Phaseolus Vulgaris L.) and Oats Snack Bar on the Proteomic Profile of Human Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Obesity
Keywords: Common beans
Oats
Proteomic Analysis
Phenolic compounds
Dietary Fiber
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Triglycerides
timeFrame: 8 weeks
measure: Glucose
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autonoma de Queretaro
name: Guadalupe Loarca-Piña, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.