Effects of Dietary Fiber on Bone Metabolism

Sponsor
Zhujiang Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05623098
Collaborator
(none)
2
1
33
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: dietary fiber nutrients

Detailed Description

In recent years, researchers have found that the incidence of bone loss in ICU patients is significantly higher than that in the control group of the same age, patients with sepsis whose bone balance is disrupted by higher overresorption, bone destruction and release of multiple active cytokines and toxins become the"Invisible killer"of the ICU, however, the pathogenesis of osteoporosis is not clear, and the existing drugs for osteoporosis can not be safely used in critically ill patients. The gastrointestinal tract is the"Initiating organ"and"Central organ" of multiple organ dysfunction and forms a complex and powerful"Gut-bone axis"with bone, which plays a key role in bone metabolism, but the mechanism is unclear. The human gut contains a dense and diverse microbial community, which plays an important role in nutrition, metabolism and immunity, small intestinal microecology can affect bone turnover through a variety of pathways, especially the metabolite short-chain fatty acid FAS (SCFAs) , which can inhibit osteoclast activity by regulating inflammatory cytokines and immune cells, promote the formation of osteoblasts and other aspects to maintain the stability of bone metabolism, and then protect the health of bones, forming a"Gut-microcology-bone"axis.

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. Therefore, based on the above research background, Investigators intend to evaluate the overall safety and efficacy of dietary fiber-containing enteral nutrition supplementation in patients with sepsis by observing changes in bone metabolism-related indicators, to provide the basis for further basic and mechanism research

Study Design

Study Type:
Observational
Anticipated Enrollment :
2 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Dietary Fiber Enteral Nutrition on Bone Metabolism in Septic Patients
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Whether to add nutrients containing dietary fiber

Outcome Measures

Primary Outcome Measures

  1. The changes of bone metabolic markers β-CTX [28 day]

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

  2. The changes of bone metabolic markers PINP [28 day]

Secondary Outcome Measures

  1. Changes in intestinal flora [28 day]

    Collect stool before and after the enrollment (the first, third, seventh and fourteenth days) ,observe the changes of intestinal flora in the two groups. Total bacterial DNA were extracted from samples using the QIAamp DNA stool Mini Kit from Qiagen according to the manufacture's protocol.

  2. Changes in short-chain fatty acid of metabolites [28 day]

    Collect stool before and after the enrollment (the first, third, seventh and fourteenth days) ,observe the changes of metabolite short chain fatty acids in the two groups. Fresh feces were collected and frozen in liquid nitrogen timely.SCFAs was extracted and quantified using a Metrohm ion chromatograph(850 Professional Ic, Metrohm, Herisau, Switzerlan) system

  3. Abdominal symptoms (abdominal distention) [28 day]

    To evaluate and compare the difference of abdominal symptoms (abdominal distension) between the two groups,It is divided into three levels according to the severity of abdominal distension, it can be divided into light, medium and severe (for example:Mild, soft abdomen, tolerable,Moderate: abdominal bulge, obvious discomfort,Severe: abdominal muscles are obviously tense/intolerable)

  4. Abdominal symptoms ( diarrhea incidence) [28 day]

    To evaluate and compare the difference of abdominal symptoms (diarrhea incidence ) between the two groups,it can be divided into light, medium and severe (for example:Mild, 3-5 times/day, 250-500ml/day,Moderate:>5 times/day, 500-1000ml/day,Severity:>5 times/day,>1500ml/day)

  5. The change of systemic inflammatory response index: the value of TNF-α in systemic inflammatory response [28 day]

    The changes of TNF-α were observed and compare before and after treatment, It can be tested in the laboratory of our hospital, the higher the value, the heavier the infection.

  6. The change of systemic inflammatory response index: the value of IL-6 in systemic inflammatory response [28 day]

    The changes of IL-6 were observed and compare before and after treatment. It can be tested in the laboratory of our hospital, the higher the value, the heavier the infection

  7. The change of systemic inflammatory response index: the value of Procalcitonin in systemic inflammatory response [28 day]

    The changes of procalcitonin were observed and compare before and after treatment, the higher the value, the heavier the infection

  8. Length of ICU stay [28 day]

    The total hospitalization time were observed before and after treatment

  9. Length of Apache II score [28 day]

    The total Apache II score were observed before and after treatment,The higher the score is, the more serious the disease is.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. The subjects voluntarily cooperated with the study and signed the informed consent form, and could be followed up

  2. Age 18-70

  3. It meets the diagnostic criteria of Sepsis 2016 Sepsis 3.0 guidelines

  4. After treatment, the Hemodynamics is stable and the patient is ready to start enteral nutrition support

  5. Those who need tube feeding for more than 14 days because of the need of illness and can not take food by mouth

Exclusion Criteria:
  1. People who have had osteoporosis in the past

  2. Admission due to fracture

  3. 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

  4. Supplement with probiotics or prebiotics alone

  5. Parturients

  6. No written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhujiang hospital Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cuiping Liu, Chief researcher, Zhujiang Hospital
ClinicalTrials.gov Identifier:
NCT05623098
Other Study ID Numbers:
  • 2022LX0036_GC
First Posted:
Nov 21, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cuiping Liu, Chief researcher, Zhujiang Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2022