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

NCT05028699 — Phase 2, Completed, 25 participants, Centro Universitario de Ciencias de la Salud, Mexico

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

Registry	NCT05028699
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	25 (Actual)
Sponsor	Centro Universitario de Ciencias de la Salud, Mexico (Other); collaborators: Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
Conditions	Dyslipidemias
Interventions	Snack (Other)
Dates	start 2021-05-03, primary completion 2021-09-10, completion 2021-09-10, first posted 2021-08-31, last updated 2021-12-10
Locations	1 site in Mexico

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Snack	Experimental	Other: Snack	32 g of a common bean baked snack per day for 28 days.
Control	No intervention

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

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 40 Years

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.

+Locations (1)

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

+Investigators

Edgar A. Rivera León, PhD, Principal investigator, Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

My Notes

Public

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