Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients

NCT02706808 | Completed

• 1 other identifier: DeniseMafra3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.

Conditions

Chronic Kidney Disease; Hemodialysis; Non-dialysis Patients

Keywords

chronic kidney disease; hemodialysis; conservative treatment; resistance starch

Outcome Measures

Primary Outcomes (2)

• Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment

  after 6 weeks with resistance starch the chronic kidney disease patients should have the gut microbiota modulated

  Change from Baseline microbiota gut at 6 weeks

• Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch

  after 6 weeks with resistance starch the chronic kidney disease patients should have the cytokines levels reduced

  Change from Baseline inflammation at 6 weeks

Study Arms (2)

resistance starch for CKD

EXPERIMENTAL

\- Intervention period (6 weeks): Group A - patients will receive 6 cookies/day containing resistant starch (18g/day); Group B - patients will receive 6 cookies/day containing placebo

Dietary Supplement: 'resistance starch for CKD

cross-over period

EXPERIMENTAL

intervention period (6 weeks): Group B - patients will receive 6 cookies/day containing resistant starch (18g/day); Group A - patients will receive 6 cookies/day containing placebo

Dietary Supplement: Placebo

Interventions

'resistance starch for CKD DIETARY_SUPPLEMENT

Intervention period (6 weeks): Group A - patients will receive 6 cookies/day containing resistant starch (18g/day); Group B - patients will receive 6 cookies/day containing placebo

resistance starch for CKD

Placebo DIETARY_SUPPLEMENT

Intervention period (6 weeks): Group B - patients will receive 6 cookies/day containing resistant starch (18g/day); Group A - patients will receive 6 cookies/day containing placebo

cross-over period

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodialysis patients with arteriovenous fistula as vascular access in the upper limb and on maintenance dialysis for at least 6 months;
• Patients under conservative treatment in stages 3a and 3b (30 to 60 mL / min) of chronic kidney disease and receiving nutritional treatment for at least 6 months (adequate supply of energy 30-35kcal/kg/day and hypoproteic 0.6 g/kg/day.

You may not qualify if:

• Patients with autoimmune and infectious diseases, diabetes, cancer and AIDS;
• Patients with catheter for hemodialysis access;
• Patients using catabolizing drugs, supplements as antioxidant vitamin, probiotics, prebiotics, synbiotics and antibiotics.
• Patients who exercise are also deleted.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260-050, Brazil

Location

Related Publications (2)

• Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

  PMID: 37870148 DERIVED

• Kemp JA, Regis de Paiva B, Fragoso Dos Santos H, Emiliano de Jesus H, Craven H, Z Ijaz U, Alvarenga Borges N, G Shiels P, Mafra D. The Impact of Enriched Resistant Starch Type-2 Cookies on the Gut Microbiome in Hemodialysis Patients: A Randomized Controlled Trial. Mol Nutr Food Res. 2021 Oct;65(19):e2100374. doi: 10.1002/mnfr.202100374. Epub 2021 Aug 22.

  PMID: 34390604 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Mafra, PhD

  Federal university fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 11, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

BR (1)