Trials / Completed
CompletedNCT04518605
Breakfast for Young Females
Breakfast for Young Females - the Importance of Breakfast Type
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Low protein breakfast | Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume \~60 g bread, 20 g jam and 250 ml juice for breakfast. |
| DIETARY_SUPPLEMENT | High protein breakfast | High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats for breakfast. |
| OTHER | Exercise training | Participants will be asked to participate in organized exercise training 3 times per week. |
Timeline
- Start date
- 2020-08-15
- Primary completion
- 2021-12-15
- Completion
- 2022-03-01
- First posted
- 2020-08-19
- Last updated
- 2022-11-17
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04518605. Inclusion in this directory is not an endorsement.