Absorption and Metabolic Profiles of a Sugar-based Beverage (SR)
Absorption Profile of a Sugar-based Beverage on Inflammatory Mechanism by Timing of Beverage Consumption Relative to Meal Intake.
Primary objective is to determine absorption profile of a sugar-based beverage on inflammatory mechanism by timing of beverage consumption relative to meal intake.
Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative and metabolic mechanism by timing of beverage consumption relative to meal intake.
The results will be served as an internal reference or negative control group to compare with polyphenol containing studies from other studies.
Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size of 12 will be recruited into this part of the study.
This study is a single-arm design utilizing a multiple sampling, and repeated measures paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute effect on inflammatory markers.
調査の概要
詳細な説明
A planned sample size of 12 will be recruited into the study. This study will require one initial screening visit, one pre-study visit, and 1 study visit. The study will take 1-2 weeks per subject to complete.
The initial screening visit will provide subject informed consent document and determine subject eligibility through height and weight measurements, vital signs, blood glucose test (finger prick), and completion of a survey related to general eating, health, and exercise habits.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at initial screening visit and collected at a pre-study visit to assess subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects will be instructed to avoid any berry products throughout the study and follow a strictly limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual diet pattern and physical activity. Prior to 10-hr study visit, a dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.
Subject will arrive at the study visit fasted for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements) , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. Thereafter, blood sample collection will occur every 1 hour for the next 10 hours. During the 10-hr study visit, subject will drink one of 3 identical placebo drinks at fasting (right after fasting blood draw), 2nd placebo drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd placebo drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw).
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety often resulting in increased intake.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60616
- Clinical Nutrition Research Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18 years of age and older
- Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for Asian population
- Nonsmoker
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol Weight stable: not gained or lost weight +/- 5 kg in previous 3 months
Exclusion Criteria:
- Men and women who smoke
- Past smokers: abstinence for minimum 2 years
- Men and women with known or suspected food intolerance, allergies or hypersensitivity
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations > 125mg/dL
- Men and women who have blood pressure >140 mmHg/90 mmHg
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are lactating
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
- Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Men and women who are vegans
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (> 4 cups/d)
- Men and women who do excessive exercise regularly or athlete
- Unstable weight: gained or lost weight +/- 5 kg in previous 3 months
- Women who are taking hormonal contraceptive
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：3 Placebo Beverages
Sugar beverage 2 hr before meal and with meal and 2 hr after meal
|
Sugar beverage 2 hr before meal, with meal and 2 hr after meal
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in inflammation markers over 10 hours after sugar beverage consumption at different time points.
時間枠：10 hr Postprandial paradigm
|
The timing influence of beverage consumption on inflammation markers in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
|
10 hr Postprandial paradigm
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in oxidative stress markers over 10 hours after sugar beverage consumption at different time points.
時間枠：10 hr
|
The timing influence of beverage consumption on oxidative stress (oxidized LDL) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
|
10 hr
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in metabolic markers over 10 hours after sugar beverage consumption at different time points.
時間枠：10 hr
|
The timing influence of sugar beverage consumption on metabolic markers (triglyceride, total cholesterol,ApoB, and insulin) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
|
10 hr
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
3 Placebo Beveragesの臨床試験
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Palacky University完了
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