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临床试验/NCT07446179
NCT07446179招募中不适用

Brewer's Spent Grain a Potential Ally for the Prevention of Type II Diabetes: Determination of Blood Glucose Absorption of New Foods

Universidad Católica del Uruguay1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Postrpandial Blood Glucose

研究概览

简要总结

The objective of this project is to determine the impact of incorporating brewers' spent grain into cookie formulations on postprandial blood glucose absorption levels following consumption. The methodology for assessing blood glucose response to cookies formulated with brewers' spent grain is described as follows.

A total of 20 participants will be recruited from the Universidad Católica del Uruguay. Volunteers will be recruited through institutional email dissemination, with Dr. María Belén Gutiérrez serving as the research contact.

Eligible participants will be healthy adults without diagnosed diseases and not taking regular medication. Inclusion criteria will be: men and women aged 18 to 75 years and a body mass index (BMI) between 18.5 and 30 kg/m². Exclusion criteria will include: pregnancy, diabetes, special dietary regimens, recent surgeries, and hypersensitivity or allergy to any of the components of the tested foods.

A physical assessment will be performed for each participant, including waist and hip circumferences, body weight, and height. Each participant will be assigned a volunteer identification code, and the data analyst will be blinded to the identity of the participants. Volunteers may withdraw from the study at any time without any consequences.

Participants will be studied on four separate occasions (one session per week). On two occasions they will receive 30 g of a commercial María cookie, and on the other two occasions 30 g of a reduced-sugar cookie containing 17% extruded brewers' spent grain. During the study period, participants will be asked to maintain their usual lifestyle.

Participants will attend the University Clinic in the morning after an 8-10 hour overnight fast. After a fasting blood sample is obtained, the corresponding treatment will be provided, and participants will have 15 minutes to consume it. Capillary blood samples will be collected at 15, 30, 45, 60, 90, and 120 minutes after the start of treatment consumption.

Blood sampling will be performed via capillary puncture using a commercially available glucometer, with disposable lancets used for each measurement and safely discarded after each sample. Sample collection will be carried out by trained personnel from the Department of Health and Well-being of the Universidad Católica del Uruguay.

During the testing period, participants will be allowed to drink up to 250 mL of water and must remain seated. For each participant and each treatment day, a data collection sheet will be used to record all measurements. After each experimental session, participants will receive a breakfast voucher.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) between 18.5 and 30 kg/m².

排除标准

  • Pregnancy
  • Recent surgerys
  • Food allergies

研究组 & 干预措施

Control biscuit

Active Comparator

干预措施: Food Intervention (Other)

Biscuit with BSG

Experimental

干预措施: Food Intervention (Other)

结局指标

主要结局

Postrpandial Blood Glucose

时间窗: From baseline to 120 minutes post-consumption

Blood glucose is measured by capillarity.

次要结局

未报告次要终点

研究者

发起方
Universidad Católica del Uruguay
申办方类型
Other
责任方
Sponsor

研究点 (1)

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