Clinical trial NCT04518605: Breakfast for Young Females
Official title: Breakfast for Young Females - the Importance of Breakfast Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Overweight Adolescents
Metabolic Disease
Keywords: Dairy protein
Breakfast content
body composition
Muscle strength
Gut microbiota/microflora
Dietary recommendations
Exercise training
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
name: Sygekassernes Helsefond
First posted: 2020-08-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Fat mass in grams
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Fat free mass in grams
timeFrame: 12 weeks
measure: Change in Lean body mass in grams
timeFrame: 12 weeks
measure: Change in Height (cm)
timeFrame: 12 weeks
measure: Change in weight (kg)
timeFrame: 12 weeks
measure: Change in BMI (m^2/kg)
timeFrame: 12 weeks
measure: Change in Waist circumference (cm)
timeFrame: 12 weeks
measure: Change in HbA1c
timeFrame: 12 weeks
measure: Change in high density lipoprotein cholesterol (HDL cholesterol)
timeFrame: 12 weeks
measure: Change in low density lipoprotein cholesterol (LDL cholesterol)
timeFrame: 12 weeks
measure: Change in triacylglycerol (TG)
timeFrame: 12 weeks
measure: Change in total cholesterol
timeFrame: 12 weeks
measure: Change in glucose
timeFrame: 12 weeks
measure: Change in insulin
timeFrame: 12 weeks
measure: Change in glucose tolerance (area under the curve)
timeFrame: 12 weeks
measure: Change in glucose peak
timeFrame: 12 weeks
measure: Change in fitness (estimated VO2-max)
timeFrame: 12 weeks
measure: Change in maximal hand grip strength
timeFrame: 12 weeks
measure: Change in maximal arm strength
timeFrame: 12 weeks
measure: Change in maximal jump height
timeFrame: 12 weeks
measure: Change in systolic and diastolic blood pressure
timeFrame: 12 weeks
Other outcomes:
measure: Change in physical activity
timeFrame: 12 weeks
measure: Changes in dietary intake
timeFrame: 12 weeks
measure: Changes in calcium and supplement intake
timeFrame: 12 weeks
measure: Change in gut microflora
timeFrame: 12 weeks
measure: Changes in faeces pH
timeFrame: 12 weeks
measure: Changes in urine metabolites
timeFrame: 12 weeks
measure: Changes in faeces metabolites
timeFrame: 12 weeks
measure: Changes in blood metabolites
timeFrame: 12 weeks
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, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: