Evaluation of Common Bean Baked Snack Consumption on Subjective Satiety, Energy Intake and Glycemic Response in People With Overweight and Normal Weight
Primary Purpose
Overweight, Healthy
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Common bean baked snack
Cooked beans
White bread
Anhydrous glucose (first session) (for glycemic index determination)
Anhydrous glucose (second session) (for glycemic index determination)
Common bean baked snack (for glycemic index determination)
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring Functional food, Common bean, Snack, Cooked beans
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.
Sites / Locations
- Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Normal weight
Overweight
Glycemic index
Arm Description
People with normal weight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
People with overweight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Determination of glycemic index under the ISO 26642:2010.
Outcomes
Primary Outcome Measures
Change in Subjective Satiety
Subjective satiety will be measured using a 100-mm visual analogue scale [0 mm (not at all) - 100 mm (completely)] at 0, 15, 30 and 45 minutes after ingestion of the test meals. The scale comprises different perceptions of satiety including: hunger, fullness, prospective food intake, and thirst.
Ad libitum energy intake (kcal)
Participants will consume sandwiches until they feel comfortably satisfied. The calories consumed will be calculated from the difference in weight of the initial and final portions of the sandwiches, using the nutritional information on the label of the package of each ingredient.
0-45 minutes Glycemic response
Capillary blood glucose (mg/dL)
0-120 minutes Glycemic response
Capillary blood glucose (mg/dL)
Secondary Outcome Measures
Full Information
NCT ID
NCT05230979
First Posted
January 17, 2022
Last Updated
July 19, 2022
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Collaborators
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
1. Study Identification
Unique Protocol Identification Number
NCT05230979
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Collaborators
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Healthy
Keywords
Functional food, Common bean, Snack, Cooked beans
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal weight
Arm Type
Experimental
Arm Description
People with normal weight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Arm Title
Overweight
Arm Type
Experimental
Arm Description
People with overweight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Arm Title
Glycemic index
Arm Type
Experimental
Arm Description
Determination of glycemic index under the ISO 26642:2010.
Intervention Type
Other
Intervention Name(s)
Common bean baked snack
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cooked beans
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
White bread
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Anhydrous glucose (first session) (for glycemic index determination)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Anhydrous glucose (second session) (for glycemic index determination)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Common bean baked snack (for glycemic index determination)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Subjective Satiety
Description
Subjective satiety will be measured using a 100-mm visual analogue scale [0 mm (not at all) - 100 mm (completely)] at 0, 15, 30 and 45 minutes after ingestion of the test meals. The scale comprises different perceptions of satiety including: hunger, fullness, prospective food intake, and thirst.
Time Frame
45 minutes period, every 15 min after ingestion of the test meal.
Title
Ad libitum energy intake (kcal)
Description
Participants will consume sandwiches until they feel comfortably satisfied. The calories consumed will be calculated from the difference in weight of the initial and final portions of the sandwiches, using the nutritional information on the label of the package of each ingredient.
Time Frame
45 minutes after ingestion of the test meal.
Title
0-45 minutes Glycemic response
Description
Capillary blood glucose (mg/dL)
Time Frame
0, 15, 30 and 45 minutes after ingestion of the test meal.
Title
0-120 minutes Glycemic response
Description
Capillary blood glucose (mg/dL)
Time Frame
0, 15, 30, 45, 60, 90, 120 minutes after ingestion of the test meal.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar A. Rivera León, PhD
Organizational Affiliation
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Non-shareable data.
Learn more about this trial
Evaluation of Common Bean Baked Snack Consumption on Subjective Satiety, Energy Intake and Glycemic Response in People With Overweight and Normal Weight
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