Breakfast for Female Adolescent - NewStart

Study Overview
=================
Brief Summary
-----------------
Investigators will test the long-term health effects of eating a dairy-based protein-rich breakfast and/or performing regular physical training for 12 weeks in 100 previous 'breakfast skipping' young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces (microbiota activity and composition), satiety and daily energy intake will be collected.

Detailed Description
-----------------
The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to skip breakfast or eat high-protein yoghurt products (300g/day) and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention period. The primary outcome will be fat mass and fat free mass. The investigators will also measure effects on weigth, waiste, health-related blood paramenters, muscle function, metabolites in urine and blood, and gut microflora and pH.

Official Title
-----------------
Breakfast for Female Adolescent - NewStart

Conditions
-----------------
Overweight Adolescents, Metabolic Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Breakfast with high protein dairy
* Other: Exercise training
* Other: Skipping breakfast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >25 exercising < 1 h per week. Exclusion Criteria: smoking illness and use of medication affecting the study outcomes allergy towards milk and yoghurt weightloss/gain >5kg the last 6 months dieting eating disorder pregnancy breast feeding unable to speak and understand danish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skipping breakfast and maintain habitual physical activity<br>Subject will skip breakfast and maintain habitual physical activity. | Other: Skipping breakfast<br>* Participants will be asked to skip breakfast.<br>|
| Experimental: High protein breakfast and maintain habitual physical activity<br>Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity. | Dietary Supplement: Breakfast with high protein dairy<br>* High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.<br>Other: Skipping breakfast<br>* Participants will be asked to skip breakfast.<br>|
| Experimental: Skipping breakfast and exercising three times per week<br>Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity) | Other: Exercise training<br>* Participants will be asked to participate in organized exercise training 3 times per week.<br>|
| Experimental: High protein breakfast and exercising three times per week<br>Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity) | Dietary Supplement: Breakfast with high protein dairy<br>* High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.<br>Other: Exercise training<br>* Participants will be asked to participate in organized exercise training 3 times per week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (DXA scan) 1 | Fat mass in grams | 12 weeks | 
| Body composition (DXA scan) 2 | Fat free mass in grams | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Blood sample measurement of HbA1c | 12 weeks | 
| LDL | Blood sample measurement of LDL | 12 weeks | 
| HDL | Blood sample measurement of HDL | 12 weeks | 
| Health related blood parameter 1 | blood sample measurement of fasting glucose | 12 weeks | 
| Health related blood parameter 2 | Blood sample measurement of fasting insulin | 12 weeks | 
| Health related parameter | Oral glucose tolerance test measured as the area under the curve | 12 weeks | 
| Fitness | Aastrand bike test | 12 weeks | 
| Muscle strength | grib strength (kg) | 12 weeks | 
| maximal jump height | maximal jump height (cm) | 12 weeks | 
| weight | Body weight (kg) | 12 weeks | 
| Height | Body hight (m) | 12 weeks | 
| BMI | weight measurement in kg, height in meters | 12 weeks | 
| Food log | 4-day food log (energy in KJ) | 12 weeks | 
| Gut microflora | by bacterial determination of faeces | 12 weeks | 
| Feaces pH | by pH determination of faeces | 12 weeks | 
| Urine metabolites | by metabolomics | 12 weeks | 
| Blood metabolites | by metabolomics | 12 weeks |