Postprandial Response to Fruit Juice

Официальное название

A Randomized, Crossover, Controlled Trial Investigating the Effects of Different Cranberry-Based Beverages on Postprandial Glucose, Insulin, and GLP-1

Обзор

The goal of this clinical trial is to determine postprandial responses to fruit juices.

Подробное описание

Fruit juice is commonly consumed as a part of a balanced diet because of hydration, flavor, and nutrient content . Dietary Guidelines for Americans 2020-2025 recognizes 100% fruit juice as a nutrient-dense beverage that can contribute to fruit and nutrient intake . Liquid form of juices may lead to faster absorption and hormonal responses . Measuring these acute metabolic responses can help clarify the role of fruit juice in dietary patterns and metabolic health .

Вмешательства

• Пищевая добавка Beverage 1
  Fruit juice with zero sugar
• Пищевая добавка Beverage 2
  Fruit juice with low sugar - formulation 1
• Пищевая добавка Beverage 3
  Fruit juice with low sugar - formulation 2
• Пищевая добавка Beverage 4
  Fruit juice with full sugar
• Пищевая добавка Beverage 5
  Fruit juice with full sugar
• Пищевая добавка Beverage 6
  Glucose control beverage

Первичные конечные точки

• Blood glucose iAUC - 2 hours [Срок оценки: 2 hours]

Вторичные конечные точки (11)

• Blood glucose maximal concentration [Срок оценки: 2 hours]
• Blood glucose time to max concentration [Срок оценки: 2 hours]
• Blood glucose change [Срок оценки: 2 hours]
• Blood insulin iAUC [Срок оценки: 2 hours]
• Blood insulin maximal concentration [Срок оценки: 2 hours]
• Blood insulin time to max concentration [Срок оценки: 2 hours]
• Blood insulin change [Срок оценки: 2 hours]
• GLP-1 iAUC [Срок оценки: 2 hours]
• GLP-1 Maximal Concentration [Срок оценки: 2 hours]
• GLP-1 Time to Max Concentration [Срок оценки: 2 hours]
• GLP-1 Change [Срок оценки: 2 hours]

Критерии участия

Критерии включения

• ≥18 to ≤45 years of age at Visit 1.
• BMI ≥18.5 and <30.0 kg/m2 at Visit 1.
• Fasting capillary glucose ≤110 mg/dL at Visit 1.
• Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit.
• Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
• Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of Visit 1, with no plans to begin use during the study period.
• Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including Cannabidiol (CBD)/Tetrahydrocannabinol (THC) products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).
• Willing to maintain habitual physical activity level throughout the duration of the study.
• Willing to maintain habitual dietary pattern throughout the duration of the study, including stable intake of current vitamins, minerals, supplements and medications not interfering with study outcomes.
• Score of 7 to 10 on the Vein Access Scale at Visit 1.
• No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

Критерии исключения

• History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Clinical Investigator.
• Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Section 9.1.1).
• Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications.
• Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications.
• Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1.
• Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
• Weight loss or gain >4.5 kg in the 60 days prior to Visit 1.
• Currently, or planning to be, on a weight loss regimen during the study.
• Use of weight loss medication within 90 days of Visit 1.
• History of gastrointestinal surgery for weight reducing purposes.
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• Known allergy or sensitivity to any ingredients or potential allergens contained in the study beverages.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• History of any major trauma or major surgical event within 60 days of Visit 1.
• Blood donation >450 mL within 60 days of Visit 2 or plans to donate blood or plasma during the study period.
• Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose) within 30 days of Visit 1) of sex hormones for contraception.
• Recent history of (within 12 months of screening; Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• Exposed to any non-registered drug product within 30 days prior to Visit 1.
• Any condition the Clinical Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Biofortis Innovation Services — Addison

Идентификаторы

NCT: NCT07103083 · BIO-2508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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