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

NCT ID: NCT05028699

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemias

Keywords

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Functional food Common bean Snack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Snack

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

Group Type EXPERIMENTAL

Snack

Intervention Type OTHER

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Snack

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco

UNKNOWN

Sponsor Role collaborator

Centro Universitario de Ciencias de la Salud, Mexico

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Escobedo Avila

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edgar A. Rivera León, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CI-09620

Identifier Type: -

Identifier Source: org_study_id