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

Completed · Not applicable · Has a placebo group

Conditions studied: Overweight, Obese, Healthy

In brief

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.

Key facts

Study ID

NCT02174640

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

9

Starts

2014-06-15

Expected to finish

2014-12-16

Last updated by the study team

2021-01-28

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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