Overweight AdolescentsNewStartNCT04419415
Breakfast for Female Adolescent - NewStart
A study testing Breakfast with high protein dairy, Exercise training and Skipping breakfast in people with Overweight Adolescents and Metabolic Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight Adolescents, Metabolic Disease
- What is being tested?
- Breakfast with high protein dairy, Exercise training and Skipping breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >25
- exercising < 1 h per week.
Who cannot join
- 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
Show all 9Show fewer
- pregnancy
- breast feeding
- unable to speak and understand danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
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.
Read the 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
- Being tested
- Breakfast with high protein dairy, Exercise training, Skipping breakfast
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast with high protein dairyDietary supplement
High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.
Exercise trainingOther
Participants will be asked to participate in organized exercise training 3 times per week.
Skipping breakfastOther
Participants will be asked to skip breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Skipping breakfast and maintain habitual physical activity | Experimental | Subject will skip breakfast and maintain habitual physical activity. Receives: Other: Skipping breakfast |
| High protein breakfast and maintain habitual physical activity | Experimental | Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity. Receives: Dietary Supplement: Breakfast with high protein dairy; Other: Skipping breakfast |
| Skipping breakfast and exercising three times per week | Experimental | Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity) Receives: Other: Exercise training |
| High protein breakfast and exercising three times per week | Experimental | Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity) Receives: Dietary Supplement: Breakfast with high protein dairy; Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition (DXA scan) 1
Fat mass in grams
Measured: 12 weeks
Body composition (DXA scan) 2
Fat free mass in grams
Measured: 12 weeks
Secondary outcomes (17)
HbA1c
Blood sample measurement of HbA1c
Measured: 12 weeks
LDL
Blood sample measurement of LDL
Measured: 12 weeks
HDL
Blood sample measurement of HDL
Measured: 12 weeks
Health related blood parameter 1
blood sample measurement of fasting glucose
Measured: 12 weeks
Health related blood parameter 2
Blood sample measurement of fasting insulin
Measured: 12 weeks
Health related parameter
Oral glucose tolerance test measured as the area under the curve
Measured: 12 weeks
Fitness
Aastrand bike test
Measured: 12 weeks
Muscle strength
grib strength (kg)
Measured: 12 weeks
maximal jump height
maximal jump height (cm)
Measured: 12 weeks
weight
Body weight (kg)
Measured: 12 weeks
Height
Body hight (m)
Measured: 12 weeks
BMI
weight measurement in kg, height in meters
Measured: 12 weeks
Food log
4-day food log (energy in KJ)
Measured: 12 weeks
Gut microflora
by bacterial determination of faeces
Measured: 12 weeks
Feaces pH
by pH determination of faeces
Measured: 12 weeks
Urine metabolites
by metabolomics
Measured: 12 weeks
Blood metabolites
by metabolomics
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Dec 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: covid-19 lock down
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdolescentsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 design
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
- Investigators
- Mette Hansen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419415
- Sponsor's protocol ID
- ProteinLab_P9_NyStart
- Acronym
- NewStart
- Status last verified
- Apr 2021
- First submitted
- 13 Mar 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast for Female Adolescent - NewStart
- ClinicalTrials.gov ID
- NCT04419415
- Acronym / sponsor ID
- NewStart / ProteinLab_P9_NyStart
- Conditions
- Overweight Adolescents, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: covid-19 lock down
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 design
| Arm | Type | Receives |
|---|---|---|
| Skipping breakfast and maintain habitual physical activity | Experimental | Other: Skipping breakfastSubject will skip breakfast and maintain habitual physical activity. |
| High protein breakfast and maintain habitual physical activity | Experimental | Dietary Supplement: Breakfast with high protein dairy, Other: Skipping breakfastSubject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity. |
| Skipping breakfast and exercising three times per week | Experimental | Other: Exercise trainingSubject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity) |
| High protein breakfast and exercising three times per week | Experimental | Dietary Supplement: Breakfast with high protein dairy, Other: Exercise trainingSubject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI >25
- exercising < 1 h per week.
Key exclusion criteria (9 listed)
- smoking
- illness and use of medication affecting the study outcomes
- allergy towards milk and yoghurt
- weightloss/gain >5kg the last 6 months
- dieting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast with high protein dairyHigh protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast. | Dietary supplement | High protein breakfast and exercising three times per week, High protein breakfast and maintain habitual physical activity |
| Exercise trainingParticipants will be asked to participate in organized exercise training 3 times per week. | Other | High protein breakfast and exercising three times per week, Skipping breakfast and exercising three times per week |
| Skipping breakfastParticipants will be asked to skip breakfast. | Other | High protein breakfast and maintain habitual physical activity, Skipping breakfast and maintain habitual physical activity |
Primary outcome
Body composition (DXA scan) 1
Time frame: 12 weeks
Fat mass in grams
Body composition (DXA scan) 2
Time frame: 12 weeks
Fat free mass in grams
17 secondary outcomes
HbA1c
Time frame: 12 weeks
LDL
Time frame: 12 weeks
HDL
Time frame: 12 weeks
Health related blood parameter 1
Time frame: 12 weeks
Health related blood parameter 2
Time frame: 12 weeks
Health related parameter
Time frame: 12 weeks
Fitness
Time frame: 12 weeks
Muscle strength
Time frame: 12 weeks
maximal jump height
Time frame: 12 weeks
weight
Time frame: 12 weeks
Height
Time frame: 12 weeks
BMI
Time frame: 12 weeks
Food log
Time frame: 12 weeks
Gut microflora
Time frame: 12 weeks
Feaces pH
Time frame: 12 weeks
Urine metabolites
Time frame: 12 weeks
Blood metabolites
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: covid-19 lock down). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Hansen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast with high protein dairy, Exercise training and Skipping breakfast in people with Overweight Adolescents and Metabolic Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: covid-19 lock down). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (DXA scan) 1 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.