Overweight and Obesity, Overweight Adolescents, Metabolic Disease
Conditions
Keywords
Dairy protein, Breakfast content, body composition, Muscle strength, Gut microbiota/microflora, Dietary recommendations, Exercise training
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTLow protein breakfast
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.
DIETARY_SUPPLEMENTHigh protein breakfast
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.
OTHERExercise training
Participants will be asked to participate in organized exercise training 3 times per week.
Sponsors
The Danish Dairy Research Foundation, Denmark
Sygekassernes Helsefond
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat mass in grams | 12 weeks | Measured by dual energy x-ray absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lean body mass in grams | 12 weeks | Measured by dual energy x-ray absorptiometry (DXA) |
| Change in Height (cm) | 12 weeks | by stadiometer |
| Change in weight (kg) | 12 weeks | Tanita Scale |
| Change in BMI (m^2/kg) | 12 weeks | Measured by height in meters and weight in kg |
| Change in Waist circumference (cm) | 12 weeks | by tape |
| Change in HbA1c | 12 weeks | by fasting blood sample |
| Change in insulin | 12 weeks | by fasting blood sample |
| Change in glucose tolerance (area under the curve) | 12 weeks | measured by a two hour oral glucose tolerance test |
| Change in glucose peak | 12 weeks | measured by a two hour oral glucose tolerance test |
| Change in fitness (estimated VO2-max) | 12 weeks | Measured by Åstrand two-step bike test |
| Change in maximal hand grip strength | 12 weeks | Measured by hand held dynamometer |
| Change in maximal arm strength | 12 weeks | Measured by costummade dynamometer |
| Change in maximal jump height | 12 weeks | Measured by squat jump with linear encoder |
| Change in systolic and diastolic blood pressure | 12 weeks | by standard blood pressure apparatus |
| Change in Fat free mass in grams | 12 weeks | Measured by dual energy x-ray absorptiometry (DXA) |
| Change in high density lipoprotein cholesterol (HDL cholesterol) | 12 weeks | by fasting blood sample |
| Change in low density lipoprotein cholesterol (LDL cholesterol) | 12 weeks | by fasting blood sample |
| Change in triacylglycerol (TG) | 12 weeks | by fasting blood sample |
| Change in total cholesterol | 12 weeks | by fasting blood sample |
| Change in glucose | 12 weeks | by fasting blood sample |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in dietary intake | 12 weeks | by 4-day dietary registration |
| Changes in calcium and supplement intake | 12 weeks | by a standard, validated food frequency questionnaire. |
| Change in gut microflora | 12 weeks | by bacterial determination of faeces |
| Changes in faeces pH | 12 weeks | by pH determination of faeces |
| Changes in urine metabolites | 12 weeks | To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine samples will be collected to perform a metabolomics analysis by mass spectroscopy. |
| Changes in faeces metabolites | 12 weeks | To evaluate the effect of the intervention on the metabolism through a metabolomic approach. Faeces samples will be collected to perform a metabolomics analysis by mass spectroscopy. |
| Changes in blood metabolites | 12 weeks | To evaluate the effect of the intervention on metabolism through a metabolomic approach. Blood samples will be collected to perform a metabolomics analysis by mass spectroscopy. |
| Change in physical activity | 12 weeks | by accelerometry |
Countries
Denmark
Outcome results
None listed