Biorhythms in Metabolic Tissues

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03276442
• Date of registration: 28/08/2017
• Prospective Registration: Yes
• Primary sponsor: Uppsala University
• Public title: Biorhythms in Metabolic Tissues
• Scientific title: Biological Rhythms in Metabolic Tissues: Impact of Diet
• Date of first enrolment: August 31, 2017
• Target sample size: 12
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03276442
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Jonathan Cedernaes, MD, PhD

• Name: Jonathan Cedernaes, M.D., Ph.D.

• Name: Jonathan Cedernaes
• Affiliation: Uppsala University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18-33 yr

- Healthy (self-reported) and not on medication

- BMI 18-28 kg/m2 (and waist circumference <102 cm), and weight stable (±5% body weight
in past 6 months)

- Non-smoker and non-nicotine user

- Regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night

- Sedentary to moderately active with regular exercise habits the last 2 months

- Regular daily meal pattern with 3 main meals

Exclusion Criteria:

- Major or chronic illness, e.g. diabetes, renal disease or inflammatory bowel disease

- Current or history of endocrine or metabolic disorders

- Psychiatric or neurological disorders (e.g. bipolar disorder, epilepsy)

- Frequent gastrointestinal symptoms

- Chronic medication

- Any sleep disorder (e.g. irregular bedtimes, symptoms of insomnia)

- Any issues with or allergies against the provided food items or utilized anesthesia

- Shift work in the preceding three months or for a long duration

- Time travel over two time zones in the preceding month

- Too much weight gain or weight loss in the preceding 6 months

- Pregnancy



Age minimum: 18 Years
Age maximum: 32 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Disturbance

Biological Clocks

Healthy

Sleep Deprivation

Intervention(s)

Other: Low-fat dietary intervention

Other: High-fat dietary intervention

Primary Outcome(s)

Changes in clock gene & associated omic circadian rhythms [Time Frame: Measured repeatedly (every 6 hours for 24 hours) during a period of extended wakefulness, following each dietary intervention (i.e. over a total period of 6-7 weeks)]

Secondary Outcome(s)

Central circadian rhythms [Time Frame: Measured repeatedly (every 1-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks)]

Rhythms of blood markers of damage to the central nervous system [Time Frame: Measured repeatedly (every 1-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks)]

Diet-induced changes in gut microbiota and relation to circadian rhythms [Time Frame: Measured throughout study participation, i.e. on average over 6-7 weeks]

Energy expenditure rhythms [Time Frame: Measured repeatedly (every 2 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks)]

24-h rhythms in blood [Time Frame: Measured repeatedly (every 2-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks)]

24-h rhythms in saliva [Time Frame: Measured repeatedly (every 2-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks)]

Wakefulness-induced changes and subsequent recovery at omic levels [Time Frame: Following each dietary intervention (i.e. over a total period of 6-7 weeks), measured repeatedly (every 2-6 hours for 24 hours) during a period of extended wakefulness, and after recovery sleep]

Urine metabolite rhythms [Time Frame: Measured throughout study participation, i.e. on average over 6-7 weeks]

Secondary ID(s)

CircHFJC2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Swedish Research Council