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Breakfast for Young Females

Not Applicable
Completed
Conditions
Overweight Adolescents
Overweight and Obesity
Metabolic Disease
Interventions
Dietary Supplement: Low protein breakfast
Dietary Supplement: High protein breakfast
Other: Exercise training
Registration Number
NCT04518605
Lead Sponsor
University of Aarhus
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
61
Inclusion Criteria
  • Body mass index > 25
  • Regular exercise < 1 hour per week
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Low protein breakfastLow protein breakfastSubject will eat a low protein breakfast and maintain their habitual physical activity.
Low protein breakfast and exercise trainingLow protein breakfastSubject 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)
Low protein breakfast and exercise trainingExercise trainingSubject 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)
High protein breakfast and exercise trainingHigh protein breakfastSubject 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)
High protein breakfast and exercise trainingExercise trainingSubject 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)
High protein breakfastHigh protein breakfastSubject will eat a high protein breakfast and maintain their habitual physical activity.
Primary Outcome Measures
NameTimeMethod
Change in Fat mass in grams12 weeks

Measured by dual energy x-ray absorptiometry (DXA)

Secondary Outcome Measures
NameTimeMethod
Change in weight (kg)12 weeks

Tanita Scale

Change in HbA1c12 weeks

by fasting blood sample

Change in glucose peak12 weeks

measured by a two hour oral glucose tolerance test

Change in high density lipoprotein cholesterol (HDL cholesterol)12 weeks

by fasting blood sample

Change in maximal hand grip strength12 weeks

Measured by hand held dynamometer

Change in Fat free mass in grams12 weeks

Measured by dual energy x-ray absorptiometry (DXA)

Change in Lean body mass in grams12 weeks

Measured by dual energy x-ray absorptiometry (DXA)

Change in BMI (m^2/kg)12 weeks

Measured by height in meters and weight in kg

Change in triacylglycerol (TG)12 weeks

by fasting blood sample

Change in insulin12 weeks

by fasting blood sample

Change in glucose12 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 fitness (estimated VO2-max)12 weeks

Measured by Åstrand two-step bike test

Change in systolic and diastolic blood pressure12 weeks

by standard blood pressure apparatus

Change in Height (cm)12 weeks

by stadiometer

Change in Waist circumference (cm)12 weeks

by tape

Change in maximal arm strength12 weeks

Measured by costummade dynamometer

Change in maximal jump height12 weeks

Measured by squat jump with linear encoder

Change in low density lipoprotein cholesterol (LDL cholesterol)12 weeks

by fasting blood sample

Change in total cholesterol12 weeks

by fasting blood sample

Trial Locations

Locations (1)

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

🇩🇰

Aarhus, Denmark

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