HealthyNCT02635139
Influence of Meal Skipping on Macronutrient Oxidation and Glucose Metabolism Under Isocaloric Conditions
A study testing Breakfast skipping and Dinner skipping in people with Healthy, run by University of Hohenheim at 1 site in Germany.
Trial summary
Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping) on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch, dinner) serves as a control. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breakfast skipping and Dinner skipping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Oct 2016
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- not obese (BMI<30)
Who cannot join
- food allergy
- smoking
- alternative nutrition habits
- chronic disease
- regular medication intake
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599
About this study
Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping) on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch, dinner) serves as a control.
Read the detailed description
The duration of the study is 7 days including 3 days with controlled diet and 4 days (including 5 nights) in a metabolic chamber at the Institute of Nutritional Medicine at the University of Hohenheim.
The study phase in the metabolic chamber consists of (i) 1 day with 3 meals/day = baseline day, (ii) 1 day with breakfast skipping, (iii) 1 day with dinner skipping, (iv) 1 washout day where the subjects leave the chamber between 7 a.m. until 7 p.m..
Beginning on the 3rd study day macronutrient and energy intake as well as the fasting periods are kept constant. To achieve comparable conditions the washout day is setted before the baseline day.
- Conditions
- Healthy
- Being tested
- Breakfast skipping, Dinner skipping
- Keywords
- meal skipping, isocaloric diet, macronutrient oxidation, glucose homeostasis, arterial stiffness
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast skippingBehavioural
18h fasting period in the morning
Dinner skippingBehavioural
18h fasting period in the evening
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Skipping | Experimental | Effect of breakfast skipping on metabolism Receives: Behavioral: Breakfast skipping |
| Dinner Skipping | Experimental | Effect of dinner skipping on metabolism Receives: Behavioral: Dinner skipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulation of glucose metabolism (substrate oxidation and insulin sensitivity)
Measured: 1 day
Secondary outcomes (2)
Actigraphy-assessed sleep quality
Measured: 1 day
cardio vascular risk (lipid profile, arterial stiffness, autonomic function)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionOct 2016
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja Bosy-Westphal, Prof PhD, Principal investigator, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635139
- Sponsor's protocol ID
- MealSkipping
- Status last verified
- Apr 2017
- First submitted
- 13 Dec 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nas A, Mirza N, Hagele F, Kahlhofer J, Keller J, Rising R, Kufer TA, Bosy-Westphal A. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr. 2017 Jun;105(6):1351-1361. doi: 10.3945/ajcn.116.151332. Epub 2017 May 10.
PubMed 28490511
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Meal Skipping on Macronutrient Oxidation and Glucose Metabolism Under Isocaloric Conditions
- ClinicalTrials.gov ID
- NCT02635139
- Acronym / sponsor ID
- MealSkipping
- Conditions
- Healthy
- Keywords
- meal skipping, isocaloric diet, macronutrient oxidation, glucose homeostasis, arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- 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.
Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping) on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch, dinner) serves as a control.
Detailed description
The duration of the study is 7 days including 3 days with controlled diet and 4 days (including 5 nights) in a metabolic chamber at the Institute of Nutritional Medicine at the University of Hohenheim.
The study phase in the metabolic chamber consists of (i) 1 day with 3 meals/day = baseline day, (ii) 1 day with breakfast skipping, (iii) 1 day with dinner skipping, (iv) 1 washout day where the subjects leave the chamber between 7 a.m. until 7 p.m..
Beginning on the 3rd study day macronutrient and energy intake as well as the fasting periods are kept constant. To achieve comparable conditions the washout day is setted before the baseline day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast Skipping | Experimental | Behavioral: Breakfast skippingEffect of breakfast skipping on metabolism |
| Dinner Skipping | Experimental | Behavioral: Dinner skippingEffect of dinner skipping on metabolism |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- not obese (BMI<30)
Key exclusion criteria (6 listed)
- food allergy
- smoking
- alternative nutrition habits
- chronic disease
- regular medication intake
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 skipping18h fasting period in the morning | Behavioural | Breakfast Skipping |
| Dinner skipping18h fasting period in the evening | Behavioural | Dinner Skipping |
Primary outcome
Regulation of glucose metabolism (substrate oxidation and insulin sensitivity)
Time frame: 1 day
2 secondary outcomes
Actigraphy-assessed sleep quality
Time frame: 1 day
cardio vascular risk (lipid profile, arterial stiffness, autonomic function)
Time frame: 1 day
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 25 Apr 2017.
- Derived from this study: PubMed 28490511Nas A, Mirza N, Hagele F, Kahlhofer J, Keller J, Rising R, Kufer TA, Bosy-Westphal A. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr. 2017 Jun;105(6):1351-1361. doi: 10.3945/ajcn.116.151332. Epub 2017 May 10.
- 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.
Anja Bosy-Westphal, Prof PhD principal investigator
University of Hohenheim, Stuttgart, Germany
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 skipping and Dinner skipping in people with Healthy, run by University of Hohenheim at 1 site in Germany.
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 6 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 25 Apr 2017. 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 Germany. 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?
Regulation of glucose metabolism (substrate oxidation and insulin sensitivity) (time frame: 1 day). 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 NCT02635139, 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 25 Apr 2017.