Breakfast for Young Females (NyStart2)

University of Aarhus

Status: Completed

Conditions: Overweight and Obesity; Overweight Adolescents; Metabolic Disease

Treatments: Other: Exercise training; Dietary Supplement: High protein breakfast; Dietary Supplement: Low protein breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT04518605

NyStart2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index > 25
• Regular exercise < 1 hour per week

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

Low protein breakfast

Experimental group

Description:

Subject will eat a low protein breakfast and maintain their habitual physical activity.

Treatment:

Dietary Supplement: Low protein breakfast

High protein breakfast

Experimental group

Description:

Subject will eat a high protein breakfast and maintain their habitual physical activity.

Treatment:

Dietary Supplement: High protein breakfast

Low protein breakfast and exercise training

Experimental group

Description:

Subject 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)

Treatment:

Other: Exercise training

Dietary Supplement: Low protein breakfast

High protein breakfast and exercise training

Experimental group

Description:

Subject 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)

Treatment:

Other: Exercise training

Dietary Supplement: High protein breakfast