Breakfast for Female Adolescent - NewStart
- Conditions
- Overweight AdolescentsMetabolic Disease
- Interventions
- Dietary Supplement: Breakfast with high protein dairyOther: Exercise trainingOther: Skipping breakfast
- Registration Number
- NCT04419415
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 25
- BMI >25
- exercising < 1 h per week.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description High protein breakfast and maintain habitual physical activity Skipping breakfast Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity. High protein breakfast and maintain habitual physical activity Breakfast with high protein dairy Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity. Skipping breakfast and exercising three times per week Exercise training Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity) High protein breakfast and exercising three times per week Exercise training 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) Skipping breakfast and maintain habitual physical activity Skipping breakfast Subject will skip breakfast and maintain habitual physical activity. High protein breakfast and exercising three times per week Breakfast with high protein dairy 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)
- Primary Outcome Measures
Name Time Method Body composition (DXA scan) 1 12 weeks Fat mass in grams
Body composition (DXA scan) 2 12 weeks Fat free mass in grams
- Secondary Outcome Measures
Name Time Method Height 12 weeks Body hight (m)
Feaces pH 12 weeks by pH determination of faeces
Blood metabolites 12 weeks by metabolomics
LDL 12 weeks Blood sample measurement of LDL
Fitness 12 weeks Aastrand bike test
BMI 12 weeks weight measurement in kg, height in meters
HbA1c 12 weeks Blood sample measurement of HbA1c
HDL 12 weeks Blood sample measurement of HDL
Muscle strength 12 weeks grib strength (kg)
maximal jump height 12 weeks maximal jump height (cm)
Urine metabolites 12 weeks by metabolomics
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
Food log 12 weeks 4-day food log (energy in KJ)
Gut microflora 12 weeks by bacterial determination of faeces
weight 12 weeks Body weight (kg)
Trial Locations
- Locations (1)
Aarhus University, Department for Public Health, Section for Sport Science
🇩🇰Aarhus, Denmark