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Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

U

Universidad Autonoma de Queretaro

Status

Completed

Conditions

Hypertriglyceridemia
Obesity

Treatments

Dietary Supplement: BOSB

Study type

Interventional

Funder types

Other

Identifiers

NCT04966494
20131004

Details and patient eligibility

About

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)

Enrollment

100 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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