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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05119153
Other study ID # 16857
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2019
Est. completion date October 31, 2021

Study information

Verified date November 2021
Source North Carolina State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study determined the effects light, medium, and dark roasted, brewed coffees on blood glucose responses in normal (n = 19) subjects.


Description:

This is a single-blinded, randomized partial block design conducted over 6 weeks in two parts. In part 1 (3 weeks), participants were randomly assigned to consume four beverages: a placebo containing water and caramel color, light, medium, or dark roast coffee before, during, or after consumption of a beverage containing 50 g of glucose. In part 2 (3 weeks), participants were randomly assigned to consume four beverages: a placebo containing water and caramel color, light, medium, or dark roast coffee before, during, or after consumption of a standardized breakfast (corn flakes cereal + skim milk) containing 50 g of glucose. In each part, fasting and postprandial glucose profiles were determined.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 31, 2021
Est. primary completion date December 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: • Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl. Exclusion Criteria: - Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl. - Weight less than 110 pounds (55 kg) - Pre-existing health conditions, such as: - High cholesterol - Hypertension - Cardiovascular disease - Gastrointestinal motility disorders - Hypo- or hyperthyroidism - Anemia - Renal disease - Liver disease, including hepatitis B or C, cholestasis, cirrhotic liver disease, or non-alcoholic fatty liver disease - Chronic or acute pancreatitis - Diabetes type 1 or 2 - Insulin resistance - Polycystic ovary syndrome - Food allergies or intolerances to coffee/caffeine/dairy/corn-based cereals. - Currently taking prescription medication - Current smoker - Consumes more than 3 alcoholic beverages per day - Pregnant or breastfeeding - Not willing to take their own blood samples with finger sticks

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo Comparator
Placebo designed to mimic coffee color.
Light Roasted Coffee
12 oz light roast coffee
Medium Roasted Coffee
12 oz medium roast coffee
Dark Roasted Coffee
12 oz dark roast coffee

Locations

Country Name City State
United States Schaub Hall, Campus Box 7624 Raleigh North Carolina

Sponsors (1)

Lead Sponsor Collaborator
North Carolina State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Blood Glucose Each week, fasted baseline and postprandial measurements taken out to 240 minutes 6 weeks
Secondary Changes in Glucose Area Under the Curve Used glucose changes over 240 minutes to construct area under the curve 6 weeks
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