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The study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial.
100 healthy controls, 100 pre-frailty and 100 frailty elderly will be included. the healthy controls will be received no intervention. The pre-frailty will be randomized at a 1:1 ratio to receive prebiotics (inulin) or placebo (maltodextrin) . The degree of improvements and correlation in frailty will be evaluated three months later.Similarly,the frailty also will be randomized at a 1:1 ratio to receive prebiotics (inulin) or placebo (maltodextrin). The degree of improvements and correlation in frailty will be evaluated three months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exprimental: Inulin | Experimental | Inulin 15 grams after dissolution by mouth, every morning for three months. |
|
| Active comparator: maltodextrin | Placebo Comparator | Placebo (maltodextrin) 15grams after dissolution by mouth, every morning for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin | Dietary Supplement | Inulin 15 grams after dissolution by mouth, every morning for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of frailty | Frailty will be diagnosed according to Fried criteria | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diversity analysis of intestinal flora | Change of diversity analysis of intestinal flora | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang xiao ming | Director of geriatrics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39286985 | Derived | Yang J, Hou L, Wang A, Shang L, Jia X, Xu R, Wang X. Prebiotics improve frailty status in community-dwelling older individuals in a double-blind, randomized, controlled trial. J Clin Invest. 2024 Aug 6;134(18):e176507. doi: 10.1172/JCI176507. |
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We will not make individual participant data (IPD) available to other researchers in a few years.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Maltodextrin | Dietary Supplement | Placebo (maltodextrin) 15g/d,Oral administration after dissolution15g/d,Oral administration after dissolution |
|
|
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |