ObesityGoDagNCT04652713
Breakfast for Young Women
A study testing Protein-rich breakfast, Carbohydrate-rich breakfast and No breakfast in people with Obesity and Wolman Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
Investigators will in a crossover study test the health effects of eating a dairy-based protein-rich breakfast, isocaloric carbohydrate-rich breakfast or no breakfast in young overweight women. 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
- Obesity, Wolman Disease, Nutrition
- What is being tested?
- Protein-rich breakfast, Carbohydrate-rich breakfast and No breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Nov 2020to 21 Nov 2023
- 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
- Body mass index > 25
- Age 18-25 years
- Regular exercise < 5 hour per week
Who cannot join
- illness and use of medication affecting the study outcomes
- allergy towards lactose or gluten
- 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
Investigators will in a crossover study test the health effects of eating a dairy-based protein-rich breakfast, isocaloric carbohydrate-rich breakfast or no breakfast in young overweight women. Determination of satiety and hunger using visual analog scores (VAS), collection of blood samples and 2x 24 hours food logs will be collected.
Read the detailed description
This study is a single-blind randomized Cross-Over trial with 30 women aged 18-30 years, each completing three trials. Participants will consume either dairy-based protein-rich breakfast, isocaloric, fiber matched, fat matched, carbohydrate-rich breakfast or no breakfast in randomized order. Three hours later a standardized ad libitum lunch will be served.
Blood samples will be collected (pre, 10 min, 30 min, 60 min, 120 min, 175 min after breakfast) and VAS rating hunger, satiety and desire to eat will be determined (pre, during breakfast, 10, 30, 60, 90, 120, 180 min, during lunch, after lunch). Twenty-four hour food logs on the day before the test day and on the test day will be collected.
Participants will be characterized by determining height (cm), weight (kg), and body composition by a dual-energy X-ray (DXA) scan before the first test day.
- Conditions
- Obesity, Wolman Disease, Nutrition
- Being tested
- Protein-rich breakfast, Carbohydrate-rich breakfast, No breakfast
- Medical subject headings
- Obesity, Wolman Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-rich breakfastOther
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.
1 glas of water (150 ml)
Carbohydrate-rich breakfastOther
Low protein breakfast 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.
1 glas of water (150 ml)
No breakfastOther
1 glas of water (150 ml)
| Study group | Role | What they receive |
|---|---|---|
| High protein breakfast | Experimental | Participants will be served a dairy-based protein-rich breakfast meal. Receives: Other: Protein-rich breakfast |
| High carbohydrate breakfast | Experimental | Participants will be served a carbohydrate-rich breakfast meal Receives: Other: Carbohydrate-rich breakfast |
| No breakfast | Experimental | Participants will be served no breakfast Receives: Other: No breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy consumption on test days
Total energy consumption on test days (24 hour food log)
Measured: 0-24 hours
Secondary outcomes (11)
Change in hunger
Visual Analog Scale (10 cm) score for feeling of hunger
Measured: 0-3 hours
Change in satiety
Visual Analog Scale (10 cm) score for feeling of satiety
Measured: 0-3 hours
change in desire
Visual Analog Scale (10 cm) score for feeling of desire to eat
Measured: 0-3 hours
Change in ghrelin
in blood sample
Measured: 0-3 hours
Change in leptin
in blood sample
Measured: 0-3 hours
Change in glucose-dependent insulinotropic polypeptide (GIP)
in blood sample
Measured: 0-3 hours
Change in Peptide YY (PYY3-36)
in blood sample
Measured: 0-3 hours
Change in insulin
in blood sample
Measured: 0-3 hours
Change in glucagon
in blood sample
Measured: 0-3 hours
Change in glucose
in blood sample
Measured: 0-3 hours
Energy consumption the day before a test day (food registration)
Total energy consumption on the day before the test day
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start24 Nov 2020
- Primary completion1 Sep 2022
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Model description
- Single-blind randomized crossover trail with three intervention meals.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- Sponsor
- Investigators
- Mette Hansen, Assoc Prof, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652713
- Sponsor's protocol ID
- P11-GoDag
- Acronym
- GoDag
- Status last verified
- May 2024
- First submitted
- 26 Nov 2020
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast for Young Women
- ClinicalTrials.gov ID
- NCT04652713
- Acronym / sponsor ID
- GoDag / P11-GoDag
- Conditions
- Obesity, Wolman Disease, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 3 Dec 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 in a crossover study test the health effects of eating a dairy-based protein-rich breakfast, isocaloric carbohydrate-rich breakfast or no breakfast in young overweight women. Determination of satiety and hunger using visual analog scores (VAS), collection of blood samples and 2x 24 hours food logs will be collected.
Detailed description
This study is a single-blind randomized Cross-Over trial with 30 women aged 18-30 years, each completing three trials. Participants will consume either dairy-based protein-rich breakfast, isocaloric, fiber matched, fat matched, carbohydrate-rich breakfast or no breakfast in randomized order. Three hours later a standardized ad libitum lunch will be served.
Blood samples will be collected (pre, 10 min, 30 min, 60 min, 120 min, 175 min after breakfast) and VAS rating hunger, satiety and desire to eat will be determined (pre, during breakfast, 10, 30, 60, 90, 120, 180 min, during lunch, after lunch). Twenty-four hour food logs on the day before the test day and on the test day will be collected.
Participants will be characterized by determining height (cm), weight (kg), and body composition by a dual-energy X-ray (DXA) scan before the first test day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blind randomized crossover trail with three intervention meals.
| Arm | Type | Receives |
|---|---|---|
| High protein breakfast | Experimental | Other: Protein-rich breakfastParticipants will be served a dairy-based protein-rich breakfast meal. |
| High carbohydrate breakfast | Experimental | Other: Carbohydrate-rich breakfastParticipants will be served a carbohydrate-rich breakfast meal |
| No breakfast | Experimental | Other: No breakfastParticipants will be served no breakfast |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index > 25
- Age 18-25 years
- Regular exercise < 5 hour per week
Key exclusion criteria (8 listed)
- illness and use of medication affecting the study outcomes
- allergy towards lactose or gluten
- 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 |
|---|---|---|
| Protein-rich 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. 1 glas of water (150 ml) | Other | High protein breakfast |
| Carbohydrate-rich breakfastLow protein breakfast 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. 1 glas of water (150 ml) | Other | High carbohydrate breakfast |
| No breakfast1 glas of water (150 ml) | Other | No breakfast |
Primary outcome
Energy consumption on test days
Time frame: 0-24 hours
Total energy consumption on test days (24 hour food log)
11 secondary outcomes
Change in hunger
Time frame: 0-3 hours
Change in satiety
Time frame: 0-3 hours
change in desire
Time frame: 0-3 hours
Change in ghrelin
Time frame: 0-3 hours
Change in leptin
Time frame: 0-3 hours
Change in glucose-dependent insulinotropic polypeptide (GIP)
Time frame: 0-3 hours
Change in Peptide YY (PYY3-36)
Time frame: 0-3 hours
Change in insulin
Time frame: 0-3 hours
Change in glucagon
Time frame: 0-3 hours
Change in glucose
Time frame: 0-3 hours
Energy consumption the day before a test day (food registration)
Time frame: 0-24 hours
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 9 May 2024.
- 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 Protein-rich breakfast, Carbohydrate-rich breakfast and No breakfast in people with Obesity and Wolman 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 3 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 9 May 2024. 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?
Energy consumption on test days (time frame: 0-24 hours). 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 9 May 2024.