Trials / Completed
CompletedNCT01603199
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. There are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients. The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | High protein high fiber diet | A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months. |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2015-07-01
- Completion
- 2016-06-01
- First posted
- 2012-05-22
- Last updated
- 2016-06-08
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT01603199. Inclusion in this directory is not an endorsement.