Overweight and ObesityNyStart2NCT04518605
Breakfast for Young Females
A study testing Low protein breakfast, High protein breakfast and Exercise training in people with Overweight and Obesity and Overweight Adolescents, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Overweight Adolescents, Metabolic Disease
- What is being tested?
- Low protein breakfast, High protein breakfast and Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2020to 1 Mar 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index > 25
- Regular exercise < 1 hour per week
Who cannot join
- 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 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
Official title: Breakfast for Young Females - the Importance of Breakfast Type
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.
Read the 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.
- Being tested
- Low protein breakfast, High protein breakfast, Exercise training
- Keywords
- Dairy protein, Breakfast content, body composition, Muscle strength, Gut microbiota/microflora, Dietary recommendations, Exercise training
- Medical subject headings
- Overweight, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low protein breakfastDietary supplement
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.
High protein breakfastDietary supplement
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.
Exercise trainingOther
Participants will be asked to participate in organized exercise training 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Low protein breakfast | Experimental | Subject will eat a low protein breakfast and maintain their habitual physical activity. Receives: Dietary Supplement: Low protein breakfast |
| High protein breakfast | Experimental | Subject will eat a high protein breakfast and maintain their habitual physical activity. Receives: Dietary Supplement: High protein breakfast |
| Low protein breakfast and exercise training | Experimental | 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) Receives: Dietary Supplement: Low protein breakfast; Other: Exercise training |
| High protein breakfast and exercise training | Experimental | 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) Receives: Dietary Supplement: High protein breakfast; Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat mass in grams
Measured by dual energy x-ray absorptiometry (DXA)
Measured: 12 weeks
Secondary outcomes (20)
Change in Fat free mass in grams
Measured by dual energy x-ray absorptiometry (DXA)
Measured: 12 weeks
Change in Lean body mass in grams
Measured by dual energy x-ray absorptiometry (DXA)
Measured: 12 weeks
Change in Height (cm)
by stadiometer
Measured: 12 weeks
Change in weight (kg)
Tanita Scale
Measured: 12 weeks
Change in BMI (m^2/kg)
Measured by height in meters and weight in kg
Measured: 12 weeks
Change in Waist circumference (cm)
by tape
Measured: 12 weeks
Change in HbA1c
by fasting blood sample
Measured: 12 weeks
Change in high density lipoprotein cholesterol (HDL cholesterol)
by fasting blood sample
Measured: 12 weeks
Change in low density lipoprotein cholesterol (LDL cholesterol)
by fasting blood sample
Measured: 12 weeks
Change in triacylglycerol (TG)
by fasting blood sample
Measured: 12 weeks
Change in total cholesterol
by fasting blood sample
Measured: 12 weeks
Change in glucose
by fasting blood sample
Measured: 12 weeks
Change in insulin
by fasting blood sample
Measured: 12 weeks
Change in glucose tolerance (area under the curve)
measured by a two hour oral glucose tolerance test
Measured: 12 weeks
Change in glucose peak
measured by a two hour oral glucose tolerance test
Measured: 12 weeks
Change in fitness (estimated VO2-max)
Measured by Åstrand two-step bike test
Measured: 12 weeks
Change in maximal hand grip strength
Measured by hand held dynamometer
Measured: 12 weeks
Change in maximal arm strength
Measured by costummade dynamometer
Measured: 12 weeks
Change in maximal jump height
Measured by squat jump with linear encoder
Measured: 12 weeks
Change in systolic and diastolic blood pressure
by standard blood pressure apparatus
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 posted19 Aug 2020
- Study start15 Aug 2020
- Primary completion15 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, Sygekassernes Helsefond
- Responsible party
- Sponsor
- Investigators
- Mette Hansen, Assoc Prof, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518605
- Sponsor's protocol ID
- NyStart2
- Acronym
- NyStart2
- Status last verified
- Jul 2021
- First submitted
- 10 Aug 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dalgaard LB, Thams L, Skovgaard Jensen J, Jorgensen AA, Breenfeldt Andersen A, Gejl KD, Bertram HC, Hansen M. No effects of high- v. low-protein breakfast on body composition and cardiometabolic health in young women with overweight: the NewStart randomised trial. Br J Nutr. 2025 Jan 14;133(1):126-135. doi: 10.1017/S0007114524003015. Epub 2024 Nov 26.
PubMed 39587799
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast for Young Females - the Importance of Breakfast Type
- ClinicalTrials.gov ID
- NCT04518605
- Acronym / sponsor ID
- NyStart2 / NyStart2
- Keywords
- Dairy protein, Breakfast content, body composition, Muscle strength, Gut microbiota/microflora, Dietary recommendations, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, Sygekassernes Helsefond
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Aug 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low protein breakfast | Experimental | Dietary Supplement: Low protein breakfastSubject will eat a low protein breakfast and maintain their habitual physical activity. |
| High protein breakfast | Experimental | Dietary Supplement: High protein breakfastSubject will eat a high protein breakfast and maintain their habitual physical activity. |
| Low protein breakfast and exercise training | Experimental | Dietary Supplement: Low protein breakfast, Other: Exercise trainingSubject 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) |
| High protein breakfast and exercise training | Experimental | Dietary Supplement: High protein breakfast, Other: Exercise trainingSubject 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index > 25
- Regular exercise < 1 hour per week
Key exclusion criteria (8 listed)
- illness and use of medication affecting the study outcomes
- allergy towards milk and yoghurt
- weightloss/gain >5kg the last 6 months
- dieting
- eating disorder
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 |
|---|---|---|
| Low protein breakfastLow 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 | Low protein breakfast, Low protein breakfast and exercise training |
| High protein breakfastHigh 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. | Dietary supplement | High protein breakfast, High protein breakfast and exercise training |
| Exercise trainingParticipants will be asked to participate in organized exercise training 3 times per week. | Other | High protein breakfast and exercise training, Low protein breakfast and exercise training |
Primary outcome
Change in Fat mass in grams
Time frame: 12 weeks
Measured by dual energy x-ray absorptiometry (DXA)
20 secondary outcomes
Change in Fat free mass in grams
Time frame: 12 weeks
Change in Lean body mass in grams
Time frame: 12 weeks
Change in Height (cm)
Time frame: 12 weeks
Change in weight (kg)
Time frame: 12 weeks
Change in BMI (m^2/kg)
Time frame: 12 weeks
Change in Waist circumference (cm)
Time frame: 12 weeks
Change in HbA1c
Time frame: 12 weeks
Change in high density lipoprotein cholesterol (HDL cholesterol)
Time frame: 12 weeks
Change in low density lipoprotein cholesterol (LDL cholesterol)
Time frame: 12 weeks
Change in triacylglycerol (TG)
Time frame: 12 weeks
Change in total cholesterol
Time frame: 12 weeks
Change in glucose
Time frame: 12 weeks
Change in insulin
Time frame: 12 weeks
Change in glucose tolerance (area under the curve)
Time frame: 12 weeks
Change in glucose peak
Time frame: 12 weeks
Change in fitness (estimated VO2-max)
Time frame: 12 weeks
Change in maximal hand grip strength
Time frame: 12 weeks
Change in maximal arm strength
Time frame: 12 weeks
Change in maximal jump height
Time frame: 12 weeks
Change in systolic and diastolic blood pressure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Derived from this study: PubMed 39587799Dalgaard LB, Thams L, Skovgaard Jensen J, Jorgensen AA, Breenfeldt Andersen A, Gejl KD, Bertram HC, Hansen M. No effects of high- v. low-protein breakfast on body composition and cardiometabolic health in young women with overweight: the NewStart randomised trial. Br J Nutr. 2025 Jan 14;133(1):126-135. doi: 10.1017/S0007114524003015. Epub 2024 Nov 26.
- 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, Assoc Prof 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 Low protein breakfast, High protein breakfast and Exercise training in people with Overweight and Obesity and Overweight Adolescents, 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 8 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: finished, as of the sponsor's last update on 17 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Fat mass in grams (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518605, which also lists 1 linked publication.
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 17 Nov 2022.