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Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Snack
Sponsored by
Centro Universitario de Ciencias de la Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Functional food, Common bean, Snack

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI between 25.0 and 29.9 kg/m2,

  • Abnormal serum lipid levels:

    • Total cholesterol: ≥200 mg/dL,
    • Low-density lipoproteins: 100 to 190 mg/dL,
    • High-density lipoproteins: <50 mg/dL in females and <40 mg/dL in males,
    • Triglycerides: 150 to 500 mg/dL.

Exclusion Criteria:

  • Pregnancy or lactation,
  • Plans to lose or gain weight in the next three months,
  • Modification of diet or physical activity in the last three months,
  • Diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease,
  • Smoking or drug use,
  • Sensitivity for bean consumption,
  • Pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify serum lipid levels.

Sites / Locations

  • Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Snack

Control

Arm Description

32 g of a common bean baked snack per day for 28 days.

Outcomes

Primary Outcome Measures

Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days
Change from baseline in the mean total cholesterol (mg/dL) at 28 days
Change from baseline in the mean triglycerides (mg/dL) at 28 days

Secondary Outcome Measures

Full Information

First Posted
August 20, 2021
Last Updated
December 9, 2021
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Collaborators
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
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1. Study Identification

Unique Protocol Identification Number
NCT05028699
Brief Title
Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels
Official Title
Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Collaborators
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco

4. Oversight

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

5. Study Description

Brief Summary
Introduction: The Mexican population consumes vegetables and snacks with the same frequency. Besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. Regular consumption of these snacks and low physical activity could promote the development of noncommunicable diseases. Common bean-based snacks are potential healthier alternatives to replace conventional snacks. Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) reduces blood lipid levels in overweight people with altered blood lipid levels. Objectives: Evaluate the effect of common bean baked snack consumption on blood lipid levels in overweight people with altered blood lipid levels. Material and Methods: Randomized crossover clinical trial, 28 patients with altered blood lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory determinations, such as total cholesterol, triglycerides, LDL, HDL, among others. Intervention phase: Common bean baked snack intervention. Control phase B: No intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
Functional food, Common bean, Snack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Snack
Arm Type
Experimental
Arm Description
32 g of a common bean baked snack per day for 28 days.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Snack
Intervention Description
Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.
Primary Outcome Measure Information:
Title
Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
Time Frame
Baseline and 28 days
Title
Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days
Time Frame
Baseline and 28 days
Title
Change from baseline in the mean total cholesterol (mg/dL) at 28 days
Time Frame
Baseline and 28 days
Title
Change from baseline in the mean triglycerides (mg/dL) at 28 days
Time Frame
Baseline and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI between 25.0 and 29.9 kg/m2, Abnormal serum lipid levels: Total cholesterol: ≥200 mg/dL, Low-density lipoproteins: 100 to 190 mg/dL, High-density lipoproteins: <50 mg/dL in females and <40 mg/dL in males, Triglycerides: 150 to 500 mg/dL. Exclusion Criteria: Pregnancy or lactation, Plans to lose or gain weight in the next three months, Modification of diet or physical activity in the last three months, Diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease, Smoking or drug use, Sensitivity for bean consumption, Pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify serum lipid levels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar A. Rivera León, PhD
Organizational Affiliation
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Non-shareable data.

Learn more about this trial

Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels

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