Absorption and Metabolic Profiles of a Sugar-based Beverage
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2014 |
| End Date: | October 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
