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

Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Other: Snack

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Snack; 32 g of a common bean baked snack per day for 28 days.	Other: Snack; Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days	Baseline and 28 days
Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days	Baseline and 28 days
Change from baseline in the mean total cholesterol (mg/dL) at 28 days	Baseline and 28 days
Change from baseline in the mean triglycerides (mg/dL) at 28 days	Baseline and 28 days

Collaborators and Investigators

• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
• Collaborators: Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
• Investigators: Principal Investigator: Edgar A. Rivera León, PhD, Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Functional food; Common bean; Snack
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CI-09620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Non-shareable data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No