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

Phase 2

Completed

• Conditions: Overweight; Healthy
• Interventions: Other: Common bean baked snack; Other: Anhydrous glucose (first session) (for glycemic index determination); Other: Cooked beans; Other: Anhydrous glucose (second session) (for glycemic index determination); Other: White bread; Other: Common bean baked snack (for glycemic index determination)

• Registration Number: NCT05230979
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Primary Completion: 2022-04-11
• Study Completion: 2022-04-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal weight	Common bean baked snack	People with normal weight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Normal weight	White bread	People with normal weight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Overweight	Cooked beans	People with overweight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Glycemic index	Anhydrous glucose (first session) (for glycemic index determination)	Determination of glycemic index under the ISO 26642:2010.
Normal weight	Cooked beans	People with normal weight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Overweight	Common bean baked snack	People with overweight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Glycemic index	Anhydrous glucose (second session) (for glycemic index determination)	Determination of glycemic index under the ISO 26642:2010.
Overweight	White bread	People with overweight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Glycemic index	Common bean baked snack (for glycemic index determination)	Determination of glycemic index under the ISO 26642:2010.

Primary Outcome Measures

Name	Time	Method
0-45 minutes Glycemic response	0, 15, 30 and 45 minutes after ingestion of the test meal.	Capillary blood glucose (mg/dL)
Change in Subjective Satiety	45 minutes period, every 15 min after ingestion of the test meal.	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.
0-120 minutes Glycemic response	0, 15, 30, 45, 60, 90, 120 minutes after ingestion of the test meal.	Capillary blood glucose (mg/dL)
Ad libitum energy intake (kcal)	45 minutes after ingestion of the test meal.	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.

Trial Locations

Locations (1)

Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico