NCT05028699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

August 20, 2021

Last Update Submit

December 9, 2021

Conditions

Dyslipidemias

Keywords

Functional foodCommon beanSnack

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Snack

EXPERIMENTAL

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

Other: Snack

Control

NO INTERVENTION

Interventions

SnackOTHER

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

Snack

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Snacks

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Edgar A. Rivera León, PhD

    Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2021

First Posted

August 31, 2021

Study Start

May 3, 2021

Primary Completion

September 10, 2021

Study Completion

September 10, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Non-shareable data.

Locations

ME(1)