Clinical trial NCT04419415: Breakfast for Female Adolescent - NewStart
Official title: Breakfast for Female Adolescent - NewStart
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight Adolescents
Metabolic Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
First posted: 2020-06-05
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 design
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body composition (DXA scan) 1
timeFrame: 12 weeks
measure: Body composition (DXA scan) 2
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: LDL
timeFrame: 12 weeks
measure: HDL
timeFrame: 12 weeks
measure: Health related blood parameter 1
timeFrame: 12 weeks
measure: Health related blood parameter 2
timeFrame: 12 weeks
measure: Health related parameter
timeFrame: 12 weeks
measure: Fitness
timeFrame: 12 weeks
measure: Muscle strength
timeFrame: 12 weeks
measure: maximal jump height
timeFrame: 12 weeks
measure: weight
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: BMI
timeFrame: 12 weeks
measure: Food log
timeFrame: 12 weeks
measure: Gut microflora
timeFrame: 12 weeks
measure: Feaces pH
timeFrame: 12 weeks
measure: Urine metabolites
timeFrame: 12 weeks
measure: Blood metabolites
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
affiliation: University of Aarhus
name: Mette Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: