Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

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DRKS-ID: DRKS00009851

Trial Description

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Title

Circadian Rhythm and Metabolism

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Trial Acronym

CRM

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URL of the Trial

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Brief Summary in Lay Language

We investigate diurnal rhythmicity in normal weight human. We include 16 healthy subjects.
Each volunteer receive high and low caloric meals at breakfast and dinner as well a fixed lunch.

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Brief Summary in Scientific Language

Because it is known that glucose tolerance underlies diurnal rhythmicity, we hypothesized that diet-induced thermogenesis (DIT) and glucose metabolism significantly differ depending on the time of day if examined under strictly controlled laboratory conditions.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00009851
Date of Registration in DRKS: 2016/01/07
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 06-094, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein

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Secondary IDs

Universal Trial Number (UTN): U1111-1178-1333

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Health Condition or Problem studied

Free text: Basic research: Obesity, circadian rhythmicity, diet-induced thermogenesis
Free text: healthy participants

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Interventions/Observational Groups

Arm 1: Volunteers consumed a predetermined high caloric (70 % of individual daily kilocalorie requirement) breakfast and low caloric dinner (10 %) combined with a fixed lunch (20 %). Total daily calorie and macronutrient content was identical in both conditions (100% of individual daily kilocalorie requirement) and corresponded to subjects’ personal basal-metabolic-rate by Harris–Benedict equation. Meals were identical to "arm 2" and - in case of need - fortified by maltodextrin with additional energy.
Arm 2: Volunteers consumed a predetermined low caloric (10 % of individual daily kilocalorie requirement) breakfast and high caloric dinner (70 %) combined with a fixed lunch (20 %). Total daily calorie and macronutrient content was identical in both conditions (100% of individual daily kilocalorie requirement) and corresponded to subjects’ personal basal-metabolic-rate by Harris–Benedict equation. Meals were identical to "arm 1" and - in case of need - fortified by maltodextrin with additional energy.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject
Control: Other
Purpose: Basic research/physiological study
Assignment: Crossover
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

diet-induced thermogenesis measured by indirect calorimetry before breakfast and dinner as well as 30, 90, 150 and 210 minutes after meal intake.

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Secondary Outcome

Glucose, insulin and C-peptide measured by blood samples before breakfast and dinner as well as 1, 2 and 4 hours after meal intake.

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

other Sektion für Psychoneurobiologie, Lübeck

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2013/07/03
Target Sample Size: 16
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Male
Minimum Age: 18 Years
Maximum Age: 30 Years

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Additional Inclusion Criteria

BMI: 20-25 kg/m²

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Exclusion Criteria

Smoker
disturbe eating behaviour (tested with FEV)
acute or chronic disease
explicit: diagnosis of migraine or other headache diseases
permanent medication
shiftworker
circadian dysrhythmia
competitive sportsman
diabetics
mental illness

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Addresses

Primary Sponsor
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- Sektion für Psychoneurobiologie
- Ms. Prof. Dr. med. Kerstin M. Oltmanns
- Ratzeburger Allee 160
- 23562 Lübeck
- Germany
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- Telephone: 04515006345
- Fax: [---]*
- E-mail: oltmanns at pnb.uni-luebeck.de
- URL: http://www.pnb.uni-luebeck.de/
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Contact for Scientific Queries
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- Sektion für Psychoneurobiologie
- Mr. Dr. med. Georg Gohla
- Ratzeburger Allee 160
- 23562 Lübeck
- Germany
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- Telephone: 04515006342
- Fax: [---]*
- E-mail: gohla at pnb.uni-luebeck.de
- URL: http://www.pnb.uni-luebeck.de/
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Contact for Public Queries
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- Sektion für Psychoneurobiologie
- Mr. Dr. med. Georg Gohla
- Ratzeburger Allee 160
- 23562 Lübeck
- Germany
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- Telephone: 04515006342
- Fax: [---]*
- E-mail: gohla at pnb.uni-luebeck.de
- URL: http://www.pnb.uni-luebeck.de/
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2014/07/10

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Trial Publications, Results and other Documents

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