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Time-To-Eat - A pilot study on a circadian diet

Phase 1
Conditions
ormal to overweight/obesity: BMI = 22 kg/m2
Registration Number
DRKS00021419
Lead Sponsor
AG Circadiane Biologie Klinik für Psychiatrie und Psychotherapie der Universität München
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
100
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).

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary objectives of the study are body weight and body mass index of the subjects (all variables are collected weekly).
Secondary Outcome Measures
NameTimeMethod
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.
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