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NCT Number: NCT03669809

The Biological Rhythm of Human Metabolite

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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Key information

Conditions

Rhythm Nodal Body Weight Lipid Metabolism Disorders Metabolic Diseases Metabolism Disorder, Lipid Metabolism and Nutrition Disorder Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location status: Recruiting

Location contact

Shanshan Shao

CONTACT

[email protected]

+8653168776094

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ling Gao

CONTACT

[email protected]

+86 53168776910

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Registry information

Official study title

Association Between Serum Metabolism Markers and Biological Rhythm

Important dates

Study start
2011
Primary completion
2050
Study completion
2050
First posted
Sep 13, 2018
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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