Effects of Dietary Fiber on Bone Metabolism

Active, not recruiting

• Conditions: Sepsis
• Interventions: Dietary Supplement: dietary fiber nutrients

• Registration Number: NCT05623098
• Lead Sponsor: Zhujiang Hospital

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.

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-08-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-18
• Last Update Submitted: 2022-11-18
• Study First Posted: 2022-11-21
• Last Update Posted: 2022-11-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dietary fiber was added to enteral nutrition preparation	dietary fiber nutrients	Dietary fiber was added to enteral nutrition preparation

Primary Outcome Measures

Name	Time	Method
The changes of bone metabolic markers PINP	28 day
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

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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)
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.
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
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)
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
Length of ICU stay	28 day	The total hospitalization time were observed before and after treatment

Trial Locations

Locations (1)

Zhujiang hospital; 🇨🇳 Guangzhou, Guangdong, China