Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether different doses of caffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption in normal weight and overweight/obese participants.

Official Title
-----------------
The Effect of Different Amounts of Coffee on Dietary Intake, Appetite-related Feeling, Appetite Hormones, Glucose Metabolism and Inflammatory Markers of Normal Weight and Overweight/Obese Individuals

Conditions
-----------------
Obesity, Inflammation

Intervention / Treatment
-----------------
* Other: coffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: apparently healthy habitual coffee drinkers (>= 1cup of coffee/day) Exclusion Criteria: smokers restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire) those who reported slimming or any other dietary regime athletes participants with a known diagnosis of either hypertension, diabetes, impaired glucose tolerance or a fasting blood glucose concentration above 125 mg/dl subjects on medication for hypertension or on medication known to alter glucose metabolism subjects who were on medication that may have an impact on appetite and sensory functioning or who reported a metabolic or endocrine disease, gastrointestinal disorders, a history of medical or surgical events that may have affected the study outcomes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: coffee3<br> | Other: coffee<br>* Comparison of different amounts of coffee<br>|
| Experimental: coffee6<br> | Other: coffee<br>* Comparison of different amounts of coffee<br>|
| Placebo Comparator: water<br> | Other: coffee<br>* Comparison of different amounts of coffee<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy intake ad libitum |  | 180 min after breakfast/drink consumption | 
| total energy intake |  | One day | 
| appetite feelings |  | fasting (-15 min) | 
| appetite feelings |  | immediately after breakfast/drink consumption (0 min) | 
| appetite feelings |  | 15 min after breakfast/drink consumption | 
| appetite feelings |  | 30 min after breakfast/drink consumption | 
| appetite feelings |  | 60 min after breakfast/drink consumption | 
| appetite feelings |  | 90 min after breakfast/drink consumption | 
| appetite feelings |  | 120 min after breakfast/drink consumption | 
| appetite feelings |  | 150 min after breakfast/drink consumption | 
| appetite feelings |  | 180 min after breakfast/drink consumption | 
| appetite hormones |  | fasting (-15 min) | 
| appetite hormones |  | immediately after breakfast/drink consumption (0 min) | 
| appetite hormones |  | 15 min after breakfast/drink consumption | 
| appetite hormones |  | 30 min after breakfast/drink consumption | 
| appetite hormones |  | 60 min after breakfast/drink consumption | 
| appetite hormones |  | 90 min after breakfast/drink consumption | 
| appetite hormones |  | 120 min after breakfast/drink consumption | 
| appetite hormones |  | 150 min after breakfast/drink consumption | 
| appetite hormones |  | 180 min after breakfast/drink consumption | 
| markers of inflammation |  | fasting (-15 min) | 
| markers of inflammation |  | immediately after breakfast/drink consumption (0 min) | 
| markers of inflammation |  | 15 min after breakfast/drink consumption | 
| markers of inflammation |  | 30 min after breakfast/drink consumption | 
| markers of inflammation |  | 60 min after breakfast/drink consumption | 
| markers of inflammation |  | 90 min after breakfast/drink consumption | 
| markers of inflammation |  | 120 min after breakfast/drink consumption | 
| markers of inflammation |  | 150 min after breakfast/drink consumption | 
| markers of inflammation |  | 180 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | fasting (-15 min) | 
| markers of glucose metabolism |  | immediately after breakfast/drink consumption (0 min) | 
| markers of glucose metabolism |  | 15 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | 30 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | 60 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | 90 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | 120 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | 150 min after breakfast/drink consumption | 
| markers of glucose metabolism |  | 180 min after breakfast/drink consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % carbohydrates ad libitum |  | 180 min after breakfast/drink consumption | 
| % carbohydrates total day |  | One day | 
| % protein ad libitum |  | 180 min after breakfast/drink consumption | 
| % protein total day |  | One day | 
| % fat |  | 180 min after breakfast/drink consumption | 
| % fat total day |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coffee, overweight/obese, appetite, energy intake, inflammation, glucose metabolism, randomized controlled trial