Acute Effects of Coffee Beverage on Postprandial Inflammation and Oxidative Stress - A Pilot Study

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.

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