Skip to main content
OpenTrials
Completed

NCT Number: NCT05028699

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Snack

Other

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

Primary outcomes

  1. Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days

    Time frame: Baseline and 28 days

  2. Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days

    Time frame: Baseline and 28 days

  3. Change from baseline in the mean total cholesterol (mg/dL) at 28 days

    Time frame: Baseline and 28 days

  4. Change from baseline in the mean triglycerides (mg/dL) at 28 days

    Time frame: Baseline and 28 days

Sponsors and collaborators

Lead sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2021
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.