Evaluation of Common Bean Baked Snack Consumption on Subjective Satiety, Energy Intake and Glycemic Response in People With Overweight and Normal Weight

NCT05230979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-07-20

No results posted yet for this study

Summary

Introduction: Overweight and obesity are associated with an unbalanced energy intake caused by unhealthy dietary habits, including a constant consumption of energy-dense foods, saturated and trans fats, refined sugars, along with a deficient protein and dietary fiber intake. Pulse consumption has been demonstrated to improve long-term body weight management. Despite these benefits, in several regions, the consumption of pulses does not meet the local recommendations. Consequently, pulse research has increased widely in order to provide food alternatives reformulated with pulses to promote their consumption.

Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) and cooked beans increases satiety, reduces energy intake and produce a low glycemic response in people with overweight and normal weight.

Objectives: Evaluate the acute effect of a common bean baked snack and cooked bean consumption on subjective satiety and energy intake in people with overweight and normal weight.

Material and Methods: Randomized crossover clinical trial, 18 subjects with normal weight and 18 subjects with overweight, 18-50 years old, consumption of 40 g of common bean baked snack, cooked beans and white bread (control). Subjective satiety, energy intake and glycemic response.

* Intervention A: Common bean baked snack.
* Intervention B: Cooked beans.
* Control: White bread.

Additionally, the glycemic index will be determined under the International Organization for Standardization (ISO) 26642:2010.

10 subjects with normal weight or overweight, 18-50 years old, consumption of 54 g of common bean baked snack and 25 g of anhydrous glucose.

* Intervention A: Common bean baked snack.
* Control: Anhydrous glucose

Conditions

Interventions

OTHER

Common bean baked snack

Participants with normal weight (n=18) and with overweight (n=18) will attend the institute after 10-14 h fasting. Initially, they are going to complete a physical activity questionnaire, and the first visual analog scale (VAS) of subjective satiety questionnaire followed by a finger-prick blood sample. Immediately, they will be instructed to consume 40 g of the preload (common bean baked snack, cooked beans or white bread) along with 100 mL of water within 10 min. The VAS and blood glucose will be measured every 15 min after starting to eat the test food. Another VAS will be used to assess the palatability of the preload products. After 45 min, an ad libitum meal consisting of freshly prepared sandwiches and 250 mL of water will be served in a single portion. Finally, the VAS of subjective satiety is going to be assessed again.

OTHER

Cooked beans

Participants with normal weight (n=18) and with overweight (n=18) will attend the institute after 10-14 h fasting. Initially, they are going to complete a physical activity questionnaire, and the first visual analog scale (VAS) of subjective satiety questionnaire followed by a finger-prick blood sample. Immediately, they will be instructed to consume 40 g of the preload (common bean baked snack, cooked beans or white bread) along with 100 mL of water within 10 min. The VAS and blood glucose will be measured every 15 min after starting to eat the test food. Another VAS will be used to assess the palatability of the preload products. After 45 min, an ad libitum meal consisting of freshly prepared sandwiches and 250 mL of water will be served in a single portion. Finally, the VAS of subjective satiety is going to be assessed again.

OTHER

White bread

Participants with normal weight (n=18) and with overweight (n=18) will attend the institute after 10-14 h fasting. Initially, they are going to complete a physical activity questionnaire, and the first visual analog scale (VAS) of subjective satiety questionnaire followed by a finger-prick blood sample. Immediately, they will be instructed to consume 40 g of the preload (common bean baked snack, cooked beans or white bread) along with 100 mL of water within 10 min. The VAS and blood glucose will be measured every 15 min after starting to eat the test food. Another VAS will be used to assess the palatability of the preload products. After 45 min, an ad libitum meal consisting of freshly prepared sandwiches and 250 mL of water will be served in a single portion. Finally, the VAS of subjective satiety is going to be assessed again.

OTHER

Anhydrous glucose (first session) (for glycemic index determination)

Participants with normal weight or overweight (n=10) will attend the institute after 10-14 h fasting. At first, two baseline finger-prick blood samples will be collected with 5 min between the samples. Then, they are going to consume a reference glucose solution containing 25 g of anhydrous glucose per 250 mL of water within 12-15 min. Later, finger-prick blood samples will be taken at 15, 30, 45, 60, 90 and 120 min after starting to drink the reference glucose solution. Areas under the glucose response curves (iAUC) will be calculated using the trapezoidal rule, ignoring the areas below the fasting value.

OTHER

Anhydrous glucose (second session) (for glycemic index determination)

Participants with normal weight or overweight (n=10) will attend the institute after 10-14 h fasting. At first, two baseline finger-prick blood samples will be collected with 5 min between the samples. Then, they are going to consume 54 g of common bean baked snack with 250 mL of water within 12-15 min. Later, finger-prick blood samples will be taken at 15, 30, 45, 60, 90 and 120 min after starting to eat the test food. Areas under the glucose response curves (iAUC) will be calculated using the trapezoidal rule, ignoring the areas below the fasting value.

OTHER

Common bean baked snack (for glycemic index determination)

Participants with normal weight or overweight (n=10) will attend the institute after 10-14 h fasting. At first, two baseline finger-prick blood samples will be collected with 5 min between the samples. Then, they are going to consume 54 g of common bean baked snack with 250 mL of water within 12-15 min. Later, finger-prick blood samples will be taken at 15, 30, 45, 60, 90 and 120 min after starting to eat the test food. Areas under the glucose response curves (iAUC) will be calculated using the trapezoidal rule, ignoring the areas below the fasting value.

Sponsors & Collaborators

  • Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco

    collaborator UNKNOWN
  • Centro Universitario de Ciencias de la Salud, Mexico

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-04-11
Completion
2022-04-11

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230979 on ClinicalTrials.gov