Metabolic Disease, Overweight Adolescents
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBreakfast with high protein dairy
High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.
OTHERExercise training
Participants will be asked to participate in organized exercise training 3 times per week.
OTHERSkipping breakfast
Participants will be asked to skip breakfast.
Sponsors
The Danish Dairy Research Foundation, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
2x2 design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition (DXA scan) 1 | 12 weeks | Fat mass in grams |
| Body composition (DXA scan) 2 | 12 weeks | Fat free mass in grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL | 12 weeks | Blood sample measurement of HDL |
| Health related blood parameter 1 | 12 weeks | blood sample measurement of fasting glucose |
| Health related blood parameter 2 | 12 weeks | Blood sample measurement of fasting insulin |
| Health related parameter | 12 weeks | Oral glucose tolerance test measured as the area under the curve |
| Fitness | 12 weeks | Aastrand bike test |
| Muscle strength | 12 weeks | grib strength (kg) |
| maximal jump height | 12 weeks | maximal jump height (cm) |
| HbA1c | 12 weeks | Blood sample measurement of HbA1c |
| Height | 12 weeks | Body hight (m) |
| BMI | 12 weeks | weight measurement in kg, height in meters |
| Food log | 12 weeks | 4-day food log (energy in KJ) |
| Gut microflora | 12 weeks | by bacterial determination of faeces |
| Feaces pH | 12 weeks | by pH determination of faeces |
| Urine metabolites | 12 weeks | by metabolomics |
| Blood metabolites | 12 weeks | by metabolomics |
| weight | 12 weeks | Body weight (kg) |
| LDL | 12 weeks | Blood sample measurement of LDL |
Countries
Denmark
Outcome results
None listed