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

NCT02174640 | Completed

• 1 other identifier: 2014-008
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obese; Healthy

Keywords

Coffee; Polyphenolics

Outcome Measures

Primary Outcomes (1)

• Changes in plasma inflammation markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal.

  The influence of coffee consumption on inflammation markers

  6 hours

Secondary Outcomes (1)

• Changes in plasma metabolic markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal

  6 hours

Other Outcomes (1)

• Changes in oxidative stress markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal

  6 hours

Study Arms (2)

Coffee

ACTIVE COMPARATOR

Coffee Beverage

Dietary Supplement: Coffee

Water

PLACEBO COMPARATOR

Water

Dietary Supplement: Water

Interventions

Coffee DIETARY_SUPPLEMENT

Coffee Beverage

Also known as: Active Comparator

Coffee

Water DIETARY_SUPPLEMENT

Water

Also known as: Placebo Comparator

Water

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Coffee; Water

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 25, 2014
• Study Start: June 15, 2014
• Primary Completion: October 27, 2014
• Study Completion: December 16, 2014
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)