NCT04419415

Breakfast for Female Adolescent - NewStart

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight Adolescents
• Metabolic Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Breakfast with high protein dairy	High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.
OTHER	Exercise training	Participants will be asked to participate in organized exercise training 3 times per week.
OTHER	Skipping breakfast	Participants will be asked to skip breakfast.

Timeline

• Start date: 2019-12-15
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2020-06-05
• Last updated: 2021-05-03

Locations

1 site across 1 country: Denmark