Clinical trial NCT05028699: Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemias
Keywords: Functional food
Common bean
Snack
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
Collaborators: name: Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
First posted: 2021-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
timeFrame: Baseline and 28 days
measure: Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days
timeFrame: Baseline and 28 days
measure: Change from baseline in the mean total cholesterol (mg/dL) at 28 days
timeFrame: Baseline and 28 days
measure: Change from baseline in the mean triglycerides (mg/dL) at 28 days
timeFrame: Baseline and 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
name: Edgar A. Rivera León, PhD
role: PRINCIPAL_INVESTIGATOR
References: