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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Other: Snack


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snack<br>32 g of a common bean baked snack per day for 28 days. | Other: Snack<br>* Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional food, Common bean, Snack