Acute Effects of Different Macronutrient Compositions and Meal Distributions of the Food

Study Overview
=================
Brief Summary
-----------------
About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.

Detailed Description
-----------------
Thirty participants come to the metabolic ward at about 8 o´clock in the fasting state and stay until lunch on four occasions each. The participants are randomized to the order of the test meals. The meals have a total caloric content of 750 kcal and have either 50% of energy from carbohydrates (low fat) or 20% of energy from carbohydrates (low carb.). The meals are consumed on one occasion in the morning or divided in 5 portions (150 kcal each) for every 30 minutes, i.e. total combinations of meal composition and of meal distribution is 4. Effects of the food on p-glucose, s-insulin, blood-lipids, hormones and on metabolic rate is measured by blood tests or by indirect calorimetry (for metabolic rate). Sense of satiety is measured by visual analogue scales.

Official Title
-----------------
Diet-induced Thermogenesis 2

Conditions
-----------------
Metabolic Rate, Plasma Glucose, Serum Insulin, Serum Triglycerides, Sense of Satiety

Intervention / Treatment
-----------------
* Other: two test meals with two different macronutrient compositions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants > 18 years with or without obesity Exclusion Criteria: Major illnesses, thyroid diseases, need to take prednisolone, psychiatric disease, inability to understand Swedish

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low carb. one meal<br>Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates | Other: two test meals with two different macronutrient compositions<br>* Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm<br>|
| Active Comparator: Low Carb. 5 small meals<br>Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates. | Other: two test meals with two different macronutrient compositions<br>* Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm<br>|
| Active Comparator: High carb. one meal<br>Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates | Other: two test meals with two different macronutrient compositions<br>* Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm<br>|
| Experimental: High carb. 5 meals<br>Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates. | Other: two test meals with two different macronutrient compositions<br>* Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic rate | The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours | During about 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on glucose and insulin | Repeated test of glucose and insulin for three hours after test meal | 3 hours |