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RecruitingNCT03669809Updated May 11, 2022

The Biological Rhythm of Human Metabolite

An observational study in Rhythm Nodal, Metabolism and Nutrition Disorder and Metabolism Disorder, Lipid, sponsored by Shandong Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Shandong Provincial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. The central clock is mainly entrained by the light-dark cycle, while the peripheral ones in organs such as liver and intestine, are more influenced by the feeding-fasting cycles. The coordination of central and peripheral clocks is thought to be essential in the maintenance of physiological homeostasis.This study aim to investigate the association between biological rhythm and metabolism.

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Conditions studied

  • Rhythm Nodal
  • Metabolism and Nutrition Disorder
  • Metabolism Disorder, Lipid

Keywords

  • biological rhythm
  • metabolism
  • hormone
  • lipid
  • bile acids
  • obesity
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In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's planned enrollment of 200 is above the median of 176 across 300 observational studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Shandong Provincial Hospital is the lead sponsor of 58 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adults aged of 18 to 30 years old.

Inclusion criteria

  • Male or female;
  • Aged of 18 to 30 years old;

Exclusion criteria

Exclusion Criteria:

  • Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome, thyroid disorders, hypertension, malignant tumor, cardiac insufficiency,hepatic or renal insufficiency, gastrointestinal disorders and acute infection;
  • Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;
  • Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;
  • Pregnancy or lactation women;
  • Obviously poor compliance.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • male, non-obese

    male with BMI\<28

  • male, obese

    male with BMI≥28

  • female, non-obese

    female with BMI\<28

  • female, obese

    female with BMI≥28

06

What researchers measure

Primary outcomes

  1. circadian rhythms of serum lipid levels (the change of serum lipid levels within 24 hours)

    Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period

Secondary outcomes

  1. circadian rhythms of gonadal hormone and gonadotropin(the change of gonadal hormone and gonadotropin within 24 hours)

    Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period

  2. circadian rhythms of serum total bile acids(the change of serum total bile acids within 24 hours)

    Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period

  3. change in urine metabolite

    Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period

  4. change in intestinal flora

    Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period

  5. change in sperm quality

    Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period

07

Study locations

1 of 1 sites recruiting
  • Shandong Provincial Hospital
    Jinan, Shandong 250021, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03669809
Lead sponsor
Shandong Provincial Hospital
Responsible party
Jia-jun Zhao (Professor, Shandong Provincial Hospital) — Principal investigator
First posted
Sep 13, 2018
Start date
May 1, 2011
Primary completion
May 1, 2050 (estimated)
Completion
May 1, 2050 (estimated)
Last update
May 11, 2022

Study contacts

Ling Gao
Contact
gaoling1@medmail.com.cn
+86 53168776910
Jiajun Zhao
study chair · Shandong Provincial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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