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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028699
• Other study ID #: CI-09620
• Status: Completed
• Phase: Phase 2
• Start date: May 3, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: December 2021
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Other:
• Snack
Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.

Locations

Country	Name	City	State
Mexico	Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico	Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days		Baseline and 28 days
Primary	Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days		Baseline and 28 days
Primary	Change from baseline in the mean total cholesterol (mg/dL) at 28 days		Baseline and 28 days
Primary	Change from baseline in the mean triglycerides (mg/dL) at 28 days		Baseline and 28 days