Trial document




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  DRKS00015057

Trial Description

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Title

Time-Restricted Feeding for the Prevention and Therapy of Lifestyle-dependent Disease

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Trial Acronym

TRF-Pilot

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URL of the Trial

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Brief Summary in Lay Language

The primary objective of the study is to investigate the feasibility of time-restricted feeding (TRF) in everyday life.
TRF is a form of interval fasting where the daily period of food intake is limited to 8-9 hours per day. This time limitation is intended to achieve an extended fasting period. The body's internal clock is closely linked to the entire metabolism and controls metabolic processes in an approximate 24-hour rhythm (circadian rhythm). The daily rhythm of our metabolism is better adjusted to earlier mealtimes due to evolution. Changes in the rhythm of food and fasting have effects on the metabolism. By the extended fasting period the circadiane rhythm is to be stabilized and thereby the metabolism be positively affected: improved blood sugar, insulin and blood fat values, better sleep.
The participants are asked to adhere to the TRF instructions as far as possible for 3 months: Limitation of the daily food intake to 8-9 hours, embedded in a larger period of 12 hours, in which also other beverages than water may be drunk, the remaining 12 hours only water. The times of the first and last food intake of the respective day and the duration and quality of sleep should be recorded in a diary. Before and after the intervention, a questionnaire on the health-related quality of life is completed, body measurements are taken and a blood test is carried out.
Potential study participants are employees of the University of Ulm or the University Hospital Ulm without known metabolic diseases or eating disorders.
The aim is to investigate the feasibility of TRF in everyday life and the adherence of the test persons. In addition, it will be examined whether intervention effects in the form of before/after differences in metabolic blood values and health-related quality of life can be determined.
In a second study arm, patients with metabolic syndrome characteristics are included in a family practice. The conduct of the trial corresponds to that described above.

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Brief Summary in Scientific Language

Prospective longitudinal study in pre-post design, without control group. Participants are employees of the University of Ulm without metabolic disorders. The intervention with a restriction of the daily intake of solid food to 8-9 hours is carried out for a period of three months. Anthropometric data (height, weight, waist circumference), laboratory data (fasting glucose, IGF-1, triglycerides, cholesterol, HDL, LDL, cortisol, LDH, CRP) and sociodemographic, health and lifestyle data are collected at the two measurement points before and after the intervention. A diary accompanying the intervention (time of first and last meal, duration and quality of sleep) completes the survey. The pilot study will test feasibility, adherence and methodologically relevant questions of TRF. The aim is to create a data basis for the conception of a further study. Primary outcome measure is the achievement of the target period of 8-9 hours of food intake. For this purpose, the percentage of days with the achievement of the target over the entire study period is calculated for each participant. Secondary outcome measures are longitudinal changes in anthropometric parameters and laboratory parameters as well as health-related quality of life (VAS from EQ-5D), sleep duration and quality.
A second study arm with patients in the general practitioner's practice is performed according to the same procedure. To this end, an amendment to the application was approved by the Ethics Committee of the Baden-Württemberg Medical Association.

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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

  •   DRKS00015057
  •   2018/08/10
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  •   yes
  •   Approved
  •   153/18, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   Prevention and therapy of lifestyle-dependent disease
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Interventions/Observational Groups

  •   Intervention in Healthy participants: restriction of the daily intake of solid food to 8-9 hours is carried out for a period of three months.
  •   Intervention in patients with any component of the metabolic syndrom: restriction of the daily intake of solid food to 8-9 hours is carried out for a period of three months.
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome measure is the achievement of the target period of 8-9 hours of food intake (recorded in a diary: time of first and last meal). For this purpose, the percentage of days with the achievement of the target over the entire study period is calculated for each participant.

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Secondary Outcome

Secondary outcome measures are longitudinal changes in anthropometric parameters (height, weight, waist circumference) and laboratory parameters (fasting glucose, IGF-1, triglycerides, cholesterol, HDL, LDL, cortisol, LDH, CRP) as well as health-related quality of life (VAS from EQ-5D), sleep duration and quality. These data are collected at the two measurement points before and after the intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/09/10
  •   90
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   67   Years
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Additional Inclusion Criteria

Arm 1: Employees of the University/University Hospital Ulm, no known metabolic diseases, no known eating disorders.
Arm 2: Patients of the GP's practice with characteristics of metabolic syndrome without eating disorders, no insulin-dependent diabetes, no hyperthyroidism

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Exclusion Criteria

Contraindications for fasting

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Addresses

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    • Institut für Allgemeinmedizin, Universität Ulm
    • Helmholtzstr. 20
    • 89081  Ulm
    • Germany
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    • Institut für Allgemeinmedizin, Universität Ulm
    • Ms.  Dr.  Dorothea  Kesztyüs 
    • Helmholtzstr. 20
    • 89081  Ulm
    • Germany
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    • Institut für Allgemeinmedizin, Universität Ulm
    • Ms.  Dr.  Dorothea  Kesztyüs 
    • Helmholtzstr. 20
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Allgemeinmedizin, Universität Ulm
    • Helmholtzstr. 20
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/06/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.