ClinicalTrials.gg
CompletedNCT05028699Updated Dec 10, 2021

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

A Phase 2 interventional study of Snack in Dyslipidemias, sponsored by Centro Universitario de Ciencias de la Salud, Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-12-10.

Sponsored by Centro Universitario de Ciencias de la Salud, Mexico · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2021, registered Aug 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Dyslipidemias

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Keywords

  • Functional food
  • Common bean
  • Snack
03

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Centro Universitario de Ciencias de la Salud, Mexico is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Snack

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

    Other: Snack

  • No intervention
    Control

Interventions

  • OtherSnack

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

06

What researchers measure

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

07

Study locations

1 site
  • Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
    Guadalajara, Jalisco 44340, Mexico
08

References and documents

Individual participant data

Plan to share: No — Non-shareable data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05028699
Lead sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Collaborators
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
Responsible party
Alejandro Escobedo Avila (Principal Investigator, Centro Universitario de Ciencias de la Salud, Mexico) — Principal investigator
First posted
Aug 31, 2021
Start date
May 3, 2021
Primary completion
Sep 10, 2021
Completion
Sep 10, 2021
Last update
Dec 10, 2021

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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