NCT03354364

Brief Summary

The purpose of this study is to determine the effects of daily consumption of snacks with and without pea hull fiber on gastrointestinal function, gastrointestinal symptoms, food intake, appetite, changes in fecal and microbial composition and activity. Fifty maintenance hemodialysis hemodialysis and CKD patients in stage 4 or 5 will be recruited to participate in a randomized, blinded, 13-week cross-over study evaluating snack foods containing 15 g/d of pea hull fiber.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

November 21, 2017

Last Update Submit

September 24, 2019

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

  • Uremic molecule - p-cresyl sulfate

    Change in serum levels of microbial metabolic product, p-cresyl sulfate

    baseline, 5 weeks, 9 weeks, 13 weeks

Secondary Outcomes (9)

  • Uremic molecules (various)

    baseline, 5 weeks, 9 weeks, 13 weeks

  • Fecal content of metabolites and minerals

    at baseline, week 5, week 9 and week 12.

  • Number of stools per week

    13 weeks

  • Stool form rating

    13 weeks

  • Gastrointestinal symptom score

    at weeks 1 through 13

  • +4 more secondary outcomes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Receives pea hull fiber snack for the first 4 weeks and then control snack for the last 4 weeks of the study with 4-week washout between them.

Dietary Supplement: Pea hull fiberDietary Supplement: Control

Group 2

ACTIVE COMPARATOR

Receives control snack for the first 4 weeks and then pea hull fiber snack for the last 4 weeks of the study with 4-week washout between them

Dietary Supplement: Pea hull fiberDietary Supplement: Control

Interventions

Pea hull fiberDIETARY_SUPPLEMENT

Snacks containing 15 g/day of ground pea hulls.

Group 1Group 2
ControlDIETARY_SUPPLEMENT

Snacks without added fiber.

Group 1Group 2

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • Kidney disease stage 4 or 5 (including dialysis).
  • Willing and able to complete the Consent Form in English.
  • Willing to have height, weight, blood pressure, handgrip strength, and body composition measured and provide demographic information (e.g. age, race, sex).
  • Willing to consume pea hull fiber snack or control snack for a 56-day period, 28 day for each type of snack.
  • Willing to complete a daily, and weekly, and monthly questionnaires regarding appetite, wellness, and transit time, and quality of life throughout the entire 13-week study.
  • Willing to provide three 24-hr diet recalls by phone during baseline and last week of each period.
  • Willing to provide 16 days of stools and 4 blood samples throughout the study.

You may not qualify if:

  • Do not meet the above criteria.
  • Have known gastrointestinal disease (i.e., inflammatory bowel disease, malignancy, celiac disease), previous colorectal surgery.
  • Allergies to ingredients in study foods provided.
  • Are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Village of Gainesville

Gainesville, Florida, 32606, United States

Location

Food Science and Human Department

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wendy J Dahl, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

December 11, 2017

Primary Completion

June 30, 2019

Study Completion

August 19, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

US(2)