This trial is active, not recruiting.

Conditions overweight, obese, healthy
Treatments coffee, water
Sponsor Institute for Food Safety and Health, United States
Start date June 2014
End date October 2017
Trial size 10 participants
Trial identifier NCT02174640, 2014-008


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
(Active Comparator)
Coffee Beverage
coffee Active Comparator
Coffee Beverage
(Placebo Comparator)
water Placebo Comparator

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants from 20 years up to 45 years old.

Inclusion Criteria: - Premenopausal women with regular menstrual cycle - Aged between 20 to 45 years old - Body Mass Index (BMI) range from 25 to 35 kg/m2; exception BMI 23 to 35 kg/m2 for Asian population - Fasting blood glucose concentration < 110 mg/dL - Fasting hs-CRP >2 mg/dL to < 10 mg/dL - Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months - No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease - Not taking any medications or dietary supplements that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study. - Able to provide informed consent - Able to comply and perform the procedures requested by the protocol Exclusion Criteria: - Men - Past smokers: abstinence for less than 2 years - Women who smoke - Women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients. - Women known to have/diagnosed with diabetes mellitus - Women who have fasting blood glucose concentrations ≥110 mg/dL - Women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries. - Women with cancer other than non-melanoma skin cancer in previous 5 years. - Women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout). - Women who are taking blood pressure lowering medication that may interfere with the outcomes of the study; e.g. diuretics. - 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. - Women who are vegetarians or vegans - Substance (alcohol or drug) abuse within the last 2 years. - Excessive coffee and tea consumers (> 4 cups/day); berry and grape consumers (>2 cups/day) - Women who do excessive exercise regularly or athlete - Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months - Women who are known to be pregnant or who are intending to become pregnant over the course of the study - Women who are lactating

Additional Information

Official title Acute Effects of Coffee Beverage on Postprandial Inflammation and Oxidative Stress - A Pilot Study
Principal investigator Britt Burton-Freeman, Ph.D
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institute for Food Safety and Health, United States.