Chronic Kidney DiseaseNCT01842087
The Effects of Fiber Fortified Foods to the Diets of Chronic Kidney Disease Patients
A study testing Fiber Fortified Food in people with Chronic Kidney Disease, run by University of Florida at 1 site in United States.
Trial summary
A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Fiber Fortified Food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- Be 18 years of age or older
- Have eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2 (stage 3,4 and 5 but who are not on dialysis)
Who cannot join
- Participants must not:
- Have been diagnosed with acute kidney injury (AKI)
- Have been diagnosed with glumerulonephritis (GN)
- Have been on immunosuppressant/steroid medications
- Be taking a probiotic supplement and refuse to discontinue it
- Be scheduled for dialysis within 3 months of study initiation
Show all 12Show fewer
- Have a history of liver disease
- Be on dialysis
- Have undergone renal transplantation
- Be breastfeeding
- Have active gastrointestinal bleeding
- Have a change in medications over the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure
A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.
Read the detailed description
Chronic Kidney Disease (CKD) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. A progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. In an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (eGFR ≤ 50 mL/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.
- Conditions
- Chronic Kidney Disease
- Being tested
- Control Food, Fiber Fortified Food
- Keywords
- Chronic Kidney Disease, Fiber, BUN, Serum Creatinine, Uremic Symptoms, Quality of Life
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control FoodOther
Also called Kellogg's Corn Pops, Publix Chocolate Chip Cookies, Kellogg's Special K Bar
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
Fiber Fortified FoodOther
Also called Kellogg's Corn Pops with Fiber, Weight Watchers Chocolate Chip Cookies, General Mills FiberOne Bar
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
| Study group | Role | What they receive |
|---|---|---|
| Control Foods | Placebo comparator | For a period of 2 weeks, participants will consume control foods in addition to their usual diets. Receives: Other: Control Food |
| Fiber Fortified Foods | Experimental | For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets. Receives: Other: Fiber Fortified Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of added fiber on blood urea nitrogen (BUN)
Blood samples (10 mL) will be taken on day 1, 14, 28, and 42. BUN will be assayed using the Urea Nitrogen Concentrated Reagent method.
Measured: up to 42 days of the study
Secondary outcomes (7)
Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)
eGFR will be calculated using the Modification of Diet in Renal Disease formula on days 1, 14, 28 and 42 of the study.
Measured: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Serum Creatinine
Serum creatinine will be assayed using the ADVIA Chemistry CRE_2c method.
Measured: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on bowel movement frequency
Participants will complete daily diaries to evaluate bowel movement frequency.
Measured: Daily
Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire
Participants will complete the Kidney Disease Quality of Life (KDQOL-36) questionnaire for 4 specific days during the study.
Measured: Days 1, 14, 28 and 42
Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)
Measured: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)
Measured: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)
Measured: Days 1, 14, 28 and 42 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Pulse Growers
- Responsible party
- Sponsor
- Investigators
- Wendy J Dahl, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842087
- Sponsor's protocol ID
- 16-2010
- Status last verified
- Mar 2020
- First submitted
- 18 Apr 2013
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salmean YA, Zello GA, Dahl WJ. Foods with added fiber improve stool frequency in individuals with chronic kidney disease with no impact on appetite or overall quality of life. BMC Res Notes. 2013 Dec 5;6:510. doi: 10.1186/1756-0500-6-510.
PubMed 24304924
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT01842087
- Acronym / sponsor ID
- 16-2010
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Fiber, BUN, Serum Creatinine, Uremic Symptoms, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.
Detailed description
Chronic Kidney Disease (CKD) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. A progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. In an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (eGFR ≤ 50 mL/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Foods | Placebo comparator | Other: Control FoodFor a period of 2 weeks, participants will consume control foods in addition to their usual diets. |
| Fiber Fortified Foods | Experimental | Other: Fiber Fortified FoodFor a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 18 years of age or older
- Have eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2 (stage 3,4 and 5 but who are not on dialysis)
Key exclusion criteria (12 listed)
- Have been diagnosed with acute kidney injury (AKI)
- Have been diagnosed with glumerulonephritis (GN)
- Have been on immunosuppressant/steroid medications
- Be taking a probiotic supplement and refuse to discontinue it
- Be scheduled for dialysis within 3 months of study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control FoodAlso: Kellogg's Corn Pops, Publix Chocolate Chip Cookies, Kellogg's Special K BarFor a period of 2 weeks, participants will consume control foods in addition to their usual diets. | Other | Control Foods |
| Fiber Fortified FoodAlso: Kellogg's Corn Pops with Fiber, Weight Watchers Chocolate Chip Cookies, General Mills FiberOne BarFor a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets. | Other | Fiber Fortified Foods |
Primary outcome
Impact of added fiber on blood urea nitrogen (BUN)
Time frame: up to 42 days of the study
Blood samples (10 mL) will be taken on day 1, 14, 28, and 42. BUN will be assayed using the Urea Nitrogen Concentrated Reagent method.
7 secondary outcomes
Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)
Time frame: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Serum Creatinine
Time frame: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on bowel movement frequency
Time frame: Daily
Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire
Time frame: Days 1, 14, 28 and 42
Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)
Time frame: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)
Time frame: Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Days 1, 14, 28 and 42 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 24304924Salmean YA, Zello GA, Dahl WJ. Foods with added fiber improve stool frequency in individuals with chronic kidney disease with no impact on appetite or overall quality of life. BMC Res Notes. 2013 Dec 5;6:510. doi: 10.1186/1756-0500-6-510.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy J Dahl, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber Fortified Food in people with Chronic Kidney Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of added fiber on blood urea nitrogen (BUN) (time frame: up to 42 days of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01842087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.