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

C

Centro Universitario de Ciencias de la Salud, Mexico

Status and phase

Completed
Phase 2

Conditions

Dyslipidemias

Treatments

Other: Snack

Study type

Interventional

Funder types

Other

Identifiers

NCT05028699
CI-09620

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 2 patient groups

Snack
Experimental group
Description:
32 g of a common bean baked snack per day for 28 days.
Treatment:
Other: Snack
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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