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Breakfast for Female Adolescent - NewStart

Not Applicable
Terminated
Conditions
Overweight Adolescents
Metabolic Disease
Interventions
Dietary Supplement: Breakfast with high protein dairy
Other: Exercise training
Other: 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
Inclusion Criteria
  • BMI >25
  • exercising < 1 h per week.
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
High protein breakfast and maintain habitual physical activitySkipping breakfastSubject 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 activityBreakfast with high protein dairySubject 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 weekExercise trainingSubject 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 weekExercise trainingSubject 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 activitySkipping breakfastSubject will skip breakfast and maintain habitual physical activity.
High protein breakfast and exercising three times per weekBreakfast with high protein dairySubject 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
NameTimeMethod
Body composition (DXA scan) 112 weeks

Fat mass in grams

Body composition (DXA scan) 212 weeks

Fat free mass in grams

Secondary Outcome Measures
NameTimeMethod
Height12 weeks

Body hight (m)

Feaces pH12 weeks

by pH determination of faeces

Blood metabolites12 weeks

by metabolomics

LDL12 weeks

Blood sample measurement of LDL

Fitness12 weeks

Aastrand bike test

BMI12 weeks

weight measurement in kg, height in meters

HbA1c12 weeks

Blood sample measurement of HbA1c

HDL12 weeks

Blood sample measurement of HDL

Muscle strength12 weeks

grib strength (kg)

maximal jump height12 weeks

maximal jump height (cm)

Urine metabolites12 weeks

by metabolomics

Health related blood parameter 112 weeks

blood sample measurement of fasting glucose

Health related blood parameter 212 weeks

Blood sample measurement of fasting insulin

Health related parameter12 weeks

Oral glucose tolerance test measured as the area under the curve

Food log12 weeks

4-day food log (energy in KJ)

Gut microflora12 weeks

by bacterial determination of faeces

weight12 weeks

Body weight (kg)

Trial Locations

Locations (1)

Aarhus University, Department for Public Health, Section for Sport Science

🇩🇰

Aarhus, Denmark

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