Effects of Dietary Fiber on Bone Metabolism

NCT05623098 | Unknown

• 1 other identifier: 2022LX0036_GC
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis.

Conditions

Sepsis

Keywords

short-chain fatty acid; sepsis; bone metabolism

Outcome Measures

Primary Outcomes (2)

• The changes of bone metabolic markers β-CTX

  The venous blood was drawn daily before and after the enrollment (the first, third, seventh and fourteenth days) ，and β- CTX for comparison

  28 day

• The changes of bone metabolic markers PINP

  28 day

Secondary Outcomes (9)

• Changes in intestinal flora

  28 day

• Changes in short-chain fatty acid of metabolites

  28 day

• Abdominal symptoms (abdominal distention)

  28 day

• Abdominal symptoms ( diarrhea incidence)

  28 day

• The change of systemic inflammatory response index: the value of TNF-α in systemic inflammatory response

  28 day

Study Arms (2)

Dietary fiber was not added to enteral nutrition preparation

Dietary fiber was not added to enteral nutrition preparation

Dietary fiber was added to enteral nutrition preparation

Dietary fiber was added to enteral nutrition preparation

Dietary Supplement: dietary fiber nutrients

Interventions

dietary fiber nutrients DIETARY_SUPPLEMENT

Whether to add nutrients containing dietary fiber

Dietary fiber was added to enteral nutrition preparation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\) sepsis 20163.0: infection + sequential organ failure assessment (Sofa) score ≥2 points. (rapid SOFA (qSOFA) scoring tool criteria: (1) respiratory frequency ≥22 beats/min; (2) change in state of consciousness; (3) systolic blood pressure ≤100 mm Hg) .

You may qualify if:

• The subjects voluntarily cooperated with the study and signed the informed consent form, and could be followed up
• Age 18-70
• It meets the diagnostic criteria of Sepsis 2016 Sepsis 3.0 guidelines
• After treatment, the Hemodynamics is stable and the patient is ready to start enteral nutrition support
• Those who need tube feeding for more than 14 days because of the need of illness and can not take food by mouth

You may not qualify if:

• People who have had osteoporosis in the past
• Admission due to fracture
• The shock was not corrected, and the patients were maintained with a large amount of vaso-active drugs (0.5 ug/kg/min of noradrenaline) , but could not be given enteral nutrition
• Supplement with probiotics or prebiotics alone
• Parturients
• No written informed consent

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief researcher

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: November 21, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CN (1)