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
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
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
NCT ID
NCT04966494
First Posted
July 2, 2021
Last Updated
July 14, 2021
Sponsor
Universidad Autonoma de Queretaro
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
Learn more about this trial
Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women
We'll reach out to this number within 24 hrs