Clinical trial NCT05230979: Evaluation of Common Bean Baked Snack Consumption on Subjective Satiety, Energy Intake and Glycemic Response in People With Overweight and Normal Weight
Official title: Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Healthy
Keywords: Functional food
Common bean
Snack
Cooked beans
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
Collaborators: name: Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
First posted: 2022-02-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* BMI between 18.0 and 29.9 kg/m2,

Exclusion Criteria:

* Pregnancy,
* Lactation,
* Established plans to lose or gain weight in the next three weeks,
* Surgical event or modification of diet or physical activity in the last three months,
* Diagnosis of diabetes, cancer, cardiovascular disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease,
* Eating disorder,
* Smoking or drug use,
* Sensitivity for common bean consumption,
* Pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify appetite or satiety.

Primary outcomes:
measure: Change in Subjective Satiety
timeFrame: 45 minutes period, every 15 min after ingestion of the test meal.
measure: Ad libitum energy intake (kcal)
timeFrame: 45 minutes after ingestion of the test meal.
measure: 0-45 minutes Glycemic response
timeFrame: 0, 15, 30 and 45 minutes after ingestion of the test meal.
measure: 0-120 minutes Glycemic response
timeFrame: 0, 15, 30, 45, 60, 90, 120 minutes after ingestion of the test meal.
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
name: Edgar A. Rivera León, PhD
role: PRINCIPAL_INVESTIGATOR
References: