Effect of 3 Different Prebiotic Sodas on Postprandial Levels of GLP-1, PYY, Transit Time and Satiety Levels: An Acute, Randomized Controlled Pilot Study in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Blood GLP-1 iAUC
研究概览
简要总结
The main objective of this study is to evaluate the acute effects of prebiotic sodas on postprandial levels of glucagon-like peptide-1 (GLP-1), peptide YY (PYY), gastric emptying, and satiety levels in healthy adults.
详细描述
The primary aim of this clinical trial is to evaluate the effects of single-dose prebiotic sodas on on postprandial levels of GLP-1.
Participants (n=15) will be healthy males and healthy, non-pregnant, non-lactating females aged 18-60 years. Participants will consume a single dose of 3 different prebiotic sodas (6 - 9 g dietary fiber and 4 g total sugar per can) and one control soda (0 g dietary fiber and 4 g total sugar per can) in a randomized, crossover design over a period of 4-12 weeks with an interval of at least 1 week and at most 3 weeks between visits.
Secondary outcomes will include evaluating the effects of single-dose consumption of the control and prebiotic sodas on postprandial PYY, gastric emptying, and satiety levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-60 years, inclusive.
- •BMI between 18.0 and 30.0 kg/m
- •Stable weight in the last 3 months (+/-5kg).
- •Willing to abstain from unusual strenuous exercise, consuming alcoholic drinks and from taking fiber supplements for 24 hours before study days.
- •Willing to refrain from smoking tobacco or e-cigarettes, and using marijuana in any form for 12h before and during study visits.
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- •Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as Ontario Health Insurance Plan (OHIP).
排除标准
- •Self-reported pregnant or breastfeeding women.
- •Subjects with a history of severe food allergies or an allergy to acetaminophen.
- •Known history of diabetes, any gastrointestinal disorder that alters the absorption of nutrients, liver disease, or the presence of any health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator (QI).
- •Subjects who are currently or in the last 2 months have been on oral or injectable GLP-1 receptor agonist (RA) medications.
- •Subjects who consume more than 14 alcoholic drinks per week, or more than 5 alcoholic drinks on any one occasion.
- •Subjects who have been on antibiotic therapy in the last 2 months.
- •Subjects taking the blood thinning drug warfarin.
- •Subjects who are habitual users of the following supplements in the past 30 days: berberine, curcumin, cinnamon, resveratrol, and gardenia.
- •Subjects which have undergone major surgery in the last 3 months.
- •Unwillingness or inability to comply with experimental procedures and to follow Inquis safety guidelines.
- •Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
研究组 & 干预措施
Control Soda
Participants will consume one 12 oz can of a control soda
干预措施: Control Soda (Other)
Prebiotic Soda - Shelf Stable
Participants will consume one 12 oz can of the shelf stable prebiotic soda
干预措施: Prebiotic Soda - Shelf Stable (Other)
Prebiotic Soda - Refrigerated
Participants will consume one 12 oz can of the refrigerated prebiotic soda
干预措施: Prebiotic Soda - Refrigerated (Other)
Prebiotic Soda - Shelf Stable + Functional Ingredient
Participants will consume one 12 oz can of the shelf stable prebiotic soda with an added functional ingredient
干预措施: Prebiotic Soda - Shelf Stable + Functional Ingredient (Other)
结局指标
主要结局
Blood GLP-1 iAUC
时间窗: For 2 hours post intervention
Incremental area under the curve (iAUC) for GLP-1 from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption.
次要结局
- Blood PYY iAUC(For 2 hours post intervention)
- Gastric Emptying Rate/Transit Time via Acetaminophen(Oral dose of acetaminophen with blood samples taken for 2 hours post intervention)
- Change in Perceived Satiety Levels(For 2 hours post intervention)