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

Phase 2

Completed

• Conditions: Dyslipidemias
• Interventions: Other: Snack

• Registration Number: NCT05028699
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Snack	Snack	32 g of a common bean baked snack per day for 28 days.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico