Chronic Kidney DiseasesNCT03689569
Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD
A study testing Resistant starch, Exercise and Starch in people with Chronic Kidney Diseases, run by Springfield College at 1 site in United States.
Trial summary
The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Resistant starch, Exercise and Starch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 26 May 2021
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
- ages of 30-75 years old,
- Must be capable of complying with and following the study protocol(diet and exercise)
- Must be capable of independently giving informed consent
Who cannot join
- kidney transplant
- currently in a structured exercise program
- on antibiotic therapy within the last month
- On a probiotic or prebiotic supplement within the last month
- a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
- HIV positive
Show all 15Show fewer
- gastric by-pass surgery
- clostridium difficile
- marijuana user
- lupus
- rheumatoid arthritis
- Hepatitis C
- Post-traumatic stress disorder
- deep vein thrombosis
- pancreatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Springfield College
Springfield, Massachusetts, 01109
About this study
Official title: Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.
Read the detailed description
The primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis CKD patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity.
The investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (CKD) and reduce key markers of inflammation. Reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. Moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Resistant starch, Exercise, Starch
- Keywords
- microbiome, inflammation, resistant starch, exercise training
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant starchDietary supplement
Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion
ExerciseBehavioural
Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity
StarchBehavioural
Patients will be given 30 grams of corn starch
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training. Receives: Behavioral: Exercise |
| Resistant Starch | Experimental | Resistant starch only: Patients randomized to this group will receive 30 g of resistant starch daily for 16 weeks. They will not be given an exercise training Receives: Dietary Supplement: Resistant starch |
| Exercise & Resistant Starch | Experimental | Exercise \& resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period Receives: Dietary Supplement: Resistant starch; Behavioral: Exercise |
| Starch | Placebo comparator | Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks Receives: Behavioral: Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hs CRP
hsCRP
Measured: baseline and after 16 weeks
Change in TNF alpha
TNFalpha
Measured: Baseline and at week 16
Change in IL6
IL6
Measured: Baseline and at week 16
Change in IL10
IL10
Measured: Baseline and at week 16
Change in MCP1
MCP1
Measured: Baseline and at week 16
Secondary outcomes (3)
Change in vascular function
Pulse wave velocity
Measured: Baseline, week 8 and week 16
Change in microbiome composition
The composition of the microbiome will be assessed at baseline and after 16 weeks
Measured: Baseline and after 16 weeks
Change in blood pressure
central blood pressure
Measured: Baseline & after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start18 Sep 2018
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An Intention-To-Treat design will be used in this study. Effects of treatment on all dependent variables will be assessed by a 2 (prebiotic supplement or control) by 2 (aerobic exercise or control) by 3 (time) mixed factor ANOVA
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Springfield College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel A. E. Headley, Ph.D FACSM, Springfield College
- Investigators
- Samuel A Headley, PhD, Principal investigator, Springfield College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689569
- Sponsor's protocol ID
- Prebiotic study
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37870148Headley SA, Chapman DJ, Germain MJ, Evans EE, Hutchinson J, Madsen KL, Ikizler TA, Miele EM, Kirton K, O'Neill E, Cornelius A, Martin B, Nindl B, Vaziri ND. The effects of 16-weeks of prebiotic supplementation and aerobic exercise training on inflammatory markers, oxidative stress, uremic toxins, and the microbiota in pre-dialysis kidney patients: a randomized controlled trial-protocol paper. BMC Nephrol. 2020 Nov 26;21(1):517. doi: 10.1186/s12882-020-02177-x.
PubMed 33243160
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
- ClinicalTrials.gov ID
- NCT03689569
- Acronym / sponsor ID
- Prebiotic study
- Conditions
- Chronic Kidney Diseases
- Keywords
- microbiome, inflammation, resistant starch, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Springfield CollegeUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.
Detailed description
The primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis CKD patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity.
The investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (CKD) and reduce key markers of inflammation. Reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. Moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- An Intention-To-Treat design will be used in this study. Effects of treatment on all dependent variables will be assessed by a 2 (prebiotic supplement or control) by 2 (aerobic exercise or control) by 3 (time) mixed factor ANOVA
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseExercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training. |
| Resistant Starch | Experimental | Dietary Supplement: Resistant starchResistant starch only: Patients randomized to this group will receive 30 g of resistant starch daily for 16 weeks. They will not be given an exercise training |
| Exercise & Resistant Starch | Experimental | Dietary Supplement: Resistant starch, Behavioral: ExerciseExercise \& resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period |
| Starch | Placebo comparator | Behavioral: StarchCorn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
- ages of 30-75 years old,
- Must be capable of complying with and following the study protocol(diet and exercise)
- Must be capable of independently giving informed consent
Key exclusion criteria (15 listed)
- kidney transplant
- currently in a structured exercise program
- on antibiotic therapy within the last month
- On a probiotic or prebiotic supplement within the last month
- a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
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 |
|---|---|---|
| Resistant starchPatients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion | Dietary supplement | Exercise & Resistant Starch, Resistant Starch |
| ExercisePatients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity | Behavioural | Exercise, Exercise & Resistant Starch |
| StarchPatients will be given 30 grams of corn starch | Behavioural | Starch |
Primary outcome
Change in hs CRP
Time frame: baseline and after 16 weeks
hsCRP
Change in TNF alpha
Time frame: Baseline and at week 16
TNFalpha
Change in IL6
Time frame: Baseline and at week 16
IL6
Change in IL10
Time frame: Baseline and at week 16
IL10
Change in MCP1
Time frame: Baseline and at week 16
MCP1
3 secondary outcomes
Change in vascular function
Time frame: Baseline, week 8 and week 16
Change in microbiome composition
Time frame: Baseline and after 16 weeks
Change in blood pressure
Time frame: Baseline & after 16 weeks
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 24 Apr 2026.
- Derived from this study: PubMed 37870148Cooper 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.
- Derived from this study: PubMed 33243160Headley SA, Chapman DJ, Germain MJ, Evans EE, Hutchinson J, Madsen KL, Ikizler TA, Miele EM, Kirton K, O'Neill E, Cornelius A, Martin B, Nindl B, Vaziri ND. The effects of 16-weeks of prebiotic supplementation and aerobic exercise training on inflammatory markers, oxidative stress, uremic toxins, and the microbiota in pre-dialysis kidney patients: a randomized controlled trial-protocol paper. BMC Nephrol. 2020 Nov 26;21(1):517. doi: 10.1186/s12882-020-02177-x.
- Individual participant dataSharing planned: No
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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.
Samuel A Headley, PhD principal investigator
Springfield College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant starch, Exercise and Starch in people with Chronic Kidney Diseases, run by Springfield College 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 4 inclusion and 15 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 24 Apr 2026. 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?
Change in hs CRP (time frame: baseline and after 16 weeks). The study lists 5 primary outcomes in all. 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 NCT03689569, which also lists 2 linked publications.
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 24 Apr 2026.