Breakfast for Young Females

Study Overview
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Brief Summary
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Investigators will test the health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.

Detailed Description
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The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period. The primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.

Official Title
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Breakfast for Young Females - the Importance of Breakfast Type

Conditions
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Overweight and Obesity, Overweight Adolescents, Metabolic Disease

Intervention / Treatment
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* Dietary Supplement: Low protein breakfast
* Dietary Supplement: High protein breakfast
* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index > 25 Regular exercise < 1 hour per week Exclusion Criteria: 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
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low protein breakfast<br>Subject will eat a low protein breakfast and maintain their habitual physical activity. | Dietary Supplement: Low protein breakfast<br>* Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume  60 g bread, 20 g jam and 250 ml juice for breakfast.<br>|
| Experimental: High protein breakfast<br>Subject will eat a high protein breakfast and maintain their habitual physical activity. | Dietary Supplement: High protein breakfast<br>* High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats for breakfast.<br>|
| Experimental: Low protein breakfast and exercise training<br>Subject will consume a low protein breakfast (bread, jam, juice) and and participate in organized exercise-training three times per week (and maintain habitual physical activity) | Dietary Supplement: Low protein breakfast<br>* Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume  60 g bread, 20 g jam and 250 ml juice for breakfast.<br>Other: Exercise training<br>* Participants will be asked to participate in organized exercise training 3 times per week.<br>|
| Experimental: High protein breakfast and exercise training<br>Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr) with oats) and and participate in organized exercise-training three times per week (and maintain habitual physical activity) | Dietary Supplement: High protein breakfast<br>* High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat mass in grams | Measured by dual energy x-ray absorptiometry (DXA) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat free mass in grams | Measured by dual energy x-ray absorptiometry (DXA) | 12 weeks | 
| Change in Lean body mass in grams | Measured by dual energy x-ray absorptiometry (DXA) | 12 weeks | 
| Change in Height (cm) | by stadiometer | 12 weeks | 
| Change in weight (kg) | Tanita Scale | 12 weeks | 
| Change in BMI (m^2/kg) | Measured by height in meters and weight in kg | 12 weeks | 
| Change in Waist circumference (cm) | by tape | 12 weeks | 
| Change in HbA1c | by fasting blood sample | 12 weeks | 
| Change in high density lipoprotein cholesterol (HDL cholesterol) | by fasting blood sample | 12 weeks | 
| Change in low density lipoprotein cholesterol (LDL cholesterol) | by fasting blood sample | 12 weeks | 
| Change in triacylglycerol (TG) | by fasting blood sample | 12 weeks | 
| Change in total cholesterol | by fasting blood sample | 12 weeks | 
| Change in glucose | by fasting blood sample | 12 weeks | 
| Change in insulin | by fasting blood sample | 12 weeks | 
| Change in glucose tolerance (area under the curve) | measured by a two hour oral glucose tolerance test | 12 weeks | 
| Change in glucose peak | measured by a two hour oral glucose tolerance test | 12 weeks | 
| Change in fitness (estimated VO2-max) | Measured by Åstrand two-step bike test | 12 weeks | 
| Change in maximal hand grip strength | Measured by hand held dynamometer | 12 weeks | 
| Change in maximal arm strength | Measured by costummade dynamometer | 12 weeks | 
| Change in maximal jump height | Measured by squat jump with linear encoder | 12 weeks | 
| Change in systolic and diastolic blood pressure | by standard blood pressure apparatus | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dairy protein, Breakfast content, body composition, Muscle strength, Gut microbiota/microflora, Dietary recommendations, Exercise training