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Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women

Primary Purpose

Hypertriglyceridemia, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BOSB
Sponsored by
Universidad Autonoma de Queretaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertriglyceridemia focused on measuring Common beans, Oats, Proteomic Analysis, Phenolic compounds, Dietary Fiber

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    BOSB Group

    Control Group

    Arm Description

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

    This group corresponded to hypertriglyceridemic women who does not consume BOSB

    Outcomes

    Primary Outcome Measures

    Triglycerides
    Significant change
    Glucose
    Significant change

    Secondary Outcome Measures

    Full Information

    First Posted
    July 2, 2021
    Last Updated
    July 14, 2021
    Sponsor
    Universidad Autonoma de Queretaro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04966494
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 5, 2013 (Actual)
    Primary Completion Date
    July 13, 2015 (Actual)
    Study Completion Date
    November 2, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de Queretaro

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia, Obesity
    Keywords
    Common beans, Oats, Proteomic Analysis, Phenolic compounds, Dietary Fiber

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BOSB Group
    Arm Type
    Experimental
    Arm Description
    This group consumed a common beans and oats snack bar (BOSB) for 8 weeks.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    This group corresponded to hypertriglyceridemic women who does not consume BOSB
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    BOSB
    Intervention Description
    BOSB consisted on a oats (26 %), common beans (30 %), water and emulsifier-based snack bar, administered daily (50 g/day) during 8 weeks.
    Primary Outcome Measure Information:
    Title
    Triglycerides
    Description
    Significant change
    Time Frame
    8 weeks
    Title
    Glucose
    Description
    Significant change
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guadalupe Loarca-Piña, Ph. D.
    Organizational Affiliation
    Universidad Autonoma de Queretaro
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be available upon reasonable request
    IPD Sharing Time Frame
    10 years
    Citations:
    PubMed Identifier
    35719139
    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.
    Results Reference
    derived

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