Effects of Dietary Fiber on Bone Metabolism

NCT ID: NCT05623098

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-31

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

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Dietary fiber was not added to enteral nutrition preparation

Dietary fiber was not added to enteral nutrition preparation

No interventions assigned to this group

Dietary fiber was added to enteral nutrition preparation

Dietary fiber was added to enteral nutrition preparation

dietary fiber nutrients

Intervention Type: DIETARY_SUPPLEMENT

Whether to add nutrients containing dietary fiber

Interventions

dietary fiber nutrients

Whether to add nutrients containing dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cuiping Liu

Chief researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhujiang hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2022LX0036_GC

Identifier Type: -

Identifier Source: org_study_id