Acute Effects of Coffee Beverage on Postprandial Inflammation and Oxidative Stress - A Pilot Study (COF1)
|ClinicalTrials.gov Identifier: NCT02174640|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : May 28, 2019
The primary objective is to test if acute supplementation with Coffee would improve antioxidant status, following consumption of a pro-oxidative high carbohydrate, high fat meal in over weight/ obese humans.
Secondary objective is to determine the ability of coffee to modify postprandial inflammation in overweight/ obese humans.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obese Healthy||Dietary Supplement: Coffee Dietary Supplement: Water||Not Applicable|
The proposed study is a single-center, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study that characterize the bioavailability and kinetic profile of coffee over 6-hour postprandial day (PPD).
A planned sample size of 10 will be recruited into the study. This study will require one initial screening visit, pre-study visit, and 2 PPDs. This study will take 3-6 weeks per subject to complete.
The trial will initiate with a screening visit, which will last for about 1-1.5 hours where the subjects' height, weight, waist circumference, fasting blood glucose, fasting hs-CRP (high sensitivity C-reactive protein) concentration, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first PPD and for the duration of the study. Prior to each PPD, a dinner meal will be provided the day before the PPD to control the second meal effect from food and beverage intake of the night before the PPD.
Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each PPD will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), 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 in the fasting state. A standard high carbohydrate and high fat test meal with either 1 cup of coffee or 1 cup of hot water will be served. Thereafter, timers will be started and blood sample will be collected at 20, 40, 60, 120, 180, 240, 300, and 360 minutes for assessment of changes in inflammation markers and relative metabolic indices. The sequence of receiving the coffee or hot water treatment at each visit will be randomly assigned based on computer generated sequences: hot water- coffee or coffee-hot water.
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 and often resulting in increased intake. Both PPD visits will be placed at least 3 days apart as well.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Acute Effects of Coffee Beverage on Postprandial Inflammation and Oxidative Stress - A Pilot Study|
|Actual Study Start Date :||June 15, 2014|
|Estimated Primary Completion Date :||October 15, 2022|
|Estimated Study Completion Date :||October 15, 2022|
Active Comparator: Coffee
Dietary Supplement: Coffee
Other Name: Active Comparator
Placebo Comparator: Water
Dietary Supplement: Water
Other Name: Placebo Comparator
- Changes in plasma inflammation markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal. [ Time Frame: 6 hours ]The influence of coffee consumption on inflammation markers
- Changes in plasma metabolic markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal [ Time Frame: 6 hours ]The influence of coffee consumption on metabolic markers
- Changes in oxidative stress markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal [ Time Frame: 6 hours ]The influence of coffee consumption on oxidative stress markers
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174640
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|Principal Investigator:||Britt Burton-Freeman, Ph.D||Illinois Institute of Technology|