Time-To-Eat - A pilot study on a circadian diet
Organizational Data
- DRKS-ID:
- DRKS00021419
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-08-21
- Last update in DRKS:
- 2024-02-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
Time-To-Eat
URL of the study
No Entry
Brief summary in lay language
It has been shown that cellular circadian clocks of the entire digestive system adjust to mealtimes in order to prepare for meals in the best possible way. Thus, if food is taken irregularly, the clocks of the digestive organs can never adjust to a specific time and nutrients cannot be optimally utilized. Studies have already shown that eating at times when the body is not prepared for it (e.g. at night) can have a negative effect on metabolism, which can lead to weight gain and even symptoms of diabetes. Conversely, restricting meals to certain times of the day in mice and humans can lead to weight loss, improved sleep quality and better general well-being. Previous studies have limited the mealtimes of test persons to a rough period of about 10-11 hours. In this pilot study, however, a personalized therapy is to be developed that examines the circadian profile of test persons with a BMI ≥ 22 kg/m2 and creates a meal plan based on this for each individual test person. The aim is to get closer to the individual ideal weight through optimized metabolism of the food.
Brief summary in scientific language
The circadian system of the body is hierarchically structured. The suprachiasmatic nucleus (SCN) in the hypothalamus is the main pacemaker of all other cellular clocks in other brain regions and in peripheral tissues. The circadian clock in the SCN and in other tissues is brought into synchrony with the daily rhythms of the environment by so-called Zeitgebers, such as light and food intake. As a result, virtually all physiological processes, including digestion and metabolism, are under the control of the circadian system and change their activity during the day depending on endogenous rhythms and exposure to Zeitgebers. As a result, in people with irregular lifestyles, the circadian system is permanently in a transient state and cannot adapt to a specific process, which can lead to physiological disorders. Shift workers, for example, suffer increasingly from overweight and diabetes. Conversely, many overweight and diabetic patients show a disturbance of their daily rhythms, which is often reflected on their behavioral level in the form of unstructured daily routines. Within the framework of this study, a dietary program (psychoeducation, short intervention) was developed in which a personalized daily structure plan with fixed repetitive mealtimes was designed, which is adapted to the individual times at which the test persons usually feel hungry. It is expected that strict adherence to mealtimes will lead to a strengthening of the circadian system in the digestive tract and thus to an optimization of the utilization of nutrients and ultimately to the adjustment of body weight to an individual ideal value.
Health condition or problem studied
- Free text:
- Normal to overweight/obesity: BMI ≥ 22 kg/m2
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Psychoeducation, creation of a personalised meal plan, electronic diary on eating behaviour over a period of 6 weeks. Voluntary follow-up after a further 4 weeks.
- Arm 2:
- Sham psychoeducation without content on circadian influences on weight, electronic diary on eating behaviour over a period of 6 weeks. Voluntary follow-up after a further 4 weeks.
Endpoints
- Primary outcome:
- The primary objectives of the study are body weight and body mass index of the subjects (all variables are collected weekly).
- Secondary outcome:
- The secondary objectives are subjective physical and psychological well-being (Health Status Questionnaire, SF-36), self-efficacy (Scale of General Self-Efficacy Expectations, SWE), the degree of depression (Inventory of Depressive Symptoms Self Revaluation, IDS-SR; Positive and Negative Affect Schedule, PANAS; Hamilton Depression Rating Scale, HAMD) as well as the Pittsburgh Sleep Quality Index (PSQI) and the chronotype (Munich Chronotype questionnaire, MCTQ). Furthermore, the subjective eating behaviour will be surveyed with a self-designed questionnaire.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- I
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Allocation is not concealed
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- Sequencing is performed in a 1:2 ratio (experimental group : control group). Simple randomisation using a randomisation table created by computer software
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Psychiatrie und Psychotherapie der Universität München München
Recruitment period and number of participants
- Planned study start date:
- 2020-09-01
- Actual study start date:
- 2020-09-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-08-15
- Target Sample Size:
- 100
- Final Sample Size:
- 100
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- All persons to whom the exclusion criteria listed below do not apply. Special emphasis is placed on the assessment of the test persons' ability to understand. Subjects are only included in the study if they are able to assess the nature and scope of the investigations. Written consent is required for inclusion. The study is conducted in accordance with the principles of the Helsinki Declaration with its amendments of Tokyo, 1975, Hong Kong, 1989, Somerset West, 1996, Seoul, 2008 and Fortaleza, 2013. The subjects must have a BMI ≥ 22 kg/m2. At present, no serious mental or metabolic diseases and no current dietary habits should be present.
Exclusion Criteria
Inability to give consent, pregnancy, current diet, intellectual, neurological or physical impairment, no serious mental or metabolic diseases, substance addictions, blindness, dependence on help with eating or going to bed (e.g. like bedridden patients).
Addresses
Primary Sponsor
- Address:
- AG Circadiane Biologie Klinik für Psychiatrie und Psychotherapie der Universität MünchenDr. Dominic LandgrafNußbaumstraße 780336 MünchenGermany
- Telephone:
- 089 4400 52753
- Fax:
- 089 4400 54741
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- AG Circadiane Biologie Klinik für Psychiatrie und Psychotherapie der Universität MünchenDr. Dominic LandgrafNußbaumstraße 780336 MünchenGermany
- Telephone:
- 089 4400 52753
- Fax:
- 089 4400 54741
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/
Contact for Public Queries
- Address:
- AG Circadiane Biologie Klinik für Psychiatrie und Psychotherapie der Universität MünchenDr. Dominic LandgrafNußbaumstraße 780336 MünchenGermany
- Telephone:
- 089 4400 52753
- Fax:
- 089 4400 54741
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/
Principal Investigator
- Address:
- AG Circadiane Biologie Klinik für Psychiatrie und Psychotherapie der Universität MünchenDr. Dominic LandgrafNußbaumstraße 780336 MünchenGermany
- Telephone:
- 089 4400 52753
- Fax:
- 089 4400 54741
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/
Sources of Monetary or Material Support
Government or public funding body, financed by tax revenue (e.g. the German DFG, BMFTR)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-12-11
- Ethics committee number:
- 19-975
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-02-19
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry