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临床试验/NCT05230979
NCT05230979已完成2 期

Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials

Centro Universitario de Ciencias de la Salud, Mexico2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
0-45 minutes Glycemic response

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI between 18.0 and 29.9 kg/m2,

排除标准

  • 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.

结局指标

主要结局

0-45 minutes Glycemic response

时间窗: 0, 15, 30 and 45 minutes after ingestion of the test meal.

Capillary blood glucose (mg/dL)

Change in Subjective Satiety

时间窗: 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

时间窗: 0, 15, 30, 45, 60, 90, 120 minutes after ingestion of the test meal.

Capillary blood glucose (mg/dL)

Ad libitum energy intake (kcal)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Centro Universitario de Ciencias de la Salud, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Escobedo Avila

Principal Investigator

Centro Universitario de Ciencias de la Salud, Mexico

研究点 (2)

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