Trial Outcomes & Findings for Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake (NCT NCT01174576)

Results Overview

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

15 min before ingestion to 3 hr post ingestion

Results posted on

2013-09-30

Participant Flow

February-Mai 2009, Athens region, voluntarily recruitment

Participant milestones

Participant milestones
Measure	Caffeinated Coffee/Decaffeinated Coffee/Water 200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order. Three combinations of treatment sequences were used: 1. Caffeinated coffee, then decaffeinated coffee, then water 2. Decaffeinated coffee first, then water, then caffeinated coffee 3. Water first, then caffeinated coffee, then decaffeinated coffee. Each treatment was separated by the other by at least one week interval. The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=16 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	27.8 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Greece	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Ghrelin Total Area Under the Curve	2669 ug*h/mL Standard Deviation 786	2593 ug*h/mL Standard Deviation 778	2672 ug*h/mL Standard Deviation 902

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve	251 pg*h/mL Standard Deviation 136	286 pg*h/mL Standard Deviation 138	259 pg*h/mL Standard Deviation 158

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve	43 ug*h/mL Standard Deviation 61	45 ug*h/mL Standard Deviation 69	61 ug*h/mL Standard Deviation 122

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 h post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Adiponectin Total Area Under the Curve	22.7 ug*h/mL Standard Deviation 8.8	22.6 ug*h/mL Standard Deviation 10.2	22.6 ug*h/mL Standard Deviation 11.0

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Inteleukin-6 Total Area Under the Curve	5.4 pg*h/mL Standard Deviation 2.1	5.5 pg*h/mL Standard Deviation 2.5	6.0 pg*h/mL Standard Deviation 2.6

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Interleukin-18 Total Area Under the Curve	818 pg*h/mL Standard Deviation 289	777 pg*h/mL Standard Deviation 280	786 pg*h/mL Standard Deviation 273

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Glucose Total Area Under the Curve	336 mg*h/dl Standard Deviation 22	329 mg*h/dl Standard Deviation 20	323 mg*h/dl Standard Deviation 20

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Insulin Total Area Under the Curve	54 uU*h/ml Standard Deviation 14	52 uU*h/ml Standard Deviation 16	52 uU*h/ml Standard Deviation 16

PRIMARY outcome

Timeframe: 15 min before ingestion to 3 hr post ingestion

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Cortisol Total Area Under the Curve	43.2 ug*h/dL Standard Deviation 11.3	39.8 ug*h/dL Standard Deviation 10.5	35.0 ug*h/dL Standard Deviation 6.9

PRIMARY outcome

Timeframe: 3 hr post ingestion

The energy of first meal 3 hr after ingestion

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Energy ad Libitum Meal	1749 kcal Standard Deviation 407	1720 kcal Standard Deviation 402	1750 kcal Standard Deviation 442

PRIMARY outcome

Timeframe: 1 d

the energy consumed at breakfast, ad libitum meal and rest of the experimental day

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Total Energy Intake	3223 kcal Standard Deviation 735	3445 kcal Standard Deviation 871	3302 kcal Standard Deviation 971

SECONDARY outcome

Timeframe: 15 min before ingestion to 21/2 hr post ingestion

Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer. Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption.

Outcome measures

Outcome measures
Measure	Caffeinated Coffee n=16 Participants 200 mL, 3 mg caffeine/kg body weight	Decaffeinated Coffee n=16 Participants 200 mL, same amount as caffeinated coffee	Water n=16 Participants 200 mL
Serum Antioxidant Capacity Total Area Under the Curve	102 lag time (min) *h Standard Deviation 30	104 lag time (min) *h Standard Deviation 37	108 lag time (min) *h Standard Deviation 32

Adverse Events

Caffeinated Coffee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Decaffeinated Coffee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary Yannakoulia

Harokopio University

Phone: 00302109549175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place