Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 3:33 AM
Study NCT ID:
NCT03689569
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084922', 'term': 'Resistant Starch'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This will be a double blind study. Neither the participant nor the investigator will know what substance (resistant starch or corn starch) the participants will be consuming.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hs CRP', 'timeFrame': 'baseline and after 16 weeks', 'description': 'hsCRP'}, {'measure': 'Change in TNF alpha', 'timeFrame': 'Baseline and at week 16', 'description': 'TNFalpha'}, {'measure': 'Change in IL6', 'timeFrame': 'Baseline and at week 16', 'description': 'IL6'}, {'measure': 'Change in IL10', 'timeFrame': 'Baseline and at week 16', 'description': 'IL10'}, {'measure': 'Change in MCP1', 'timeFrame': 'Baseline and at week 16', 'description': 'MCP1'}], 'secondaryOutcomes': [{'measure': 'Change in vascular function', 'timeFrame': 'Baseline, week 8 and week 16', 'description': 'Pulse wave velocity'}, {'measure': 'Change in microbiome composition', 'timeFrame': 'Baseline and after 16 weeks', 'description': 'The composition of the microbiome will be assessed at baseline and after 16 weeks'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline & after 16 weeks', 'description': 'central blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'inflammation', 'resistant starch', 'exercise training'], 'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '37870148', 'type': 'DERIVED', 'citation': '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': '33243160', 'type': 'DERIVED', 'citation': "Headley 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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),\n* ages of 30-75 years old,\n* Must be capable of complying with and following the study protocol(diet and exercise)\n* Must be capable of independently giving informed consent\n\nExclusion Criteria:\n\n* kidney transplant\n* currently in a structured exercise program\n* on antibiotic therapy within the last month\n* On a probiotic or prebiotic supplement within the last month\n* a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion\n* HIV positive\n* gastric by-pass surgery\n* clostridium difficile\n* marijuana user\n* lupus\n* rheumatoid arthritis\n* Hepatitis C\n* Post-traumatic stress disorder\n* deep vein thrombosis\n* pancreatitis'}, 'identificationModule': {'nctId': 'NCT03689569', 'briefTitle': 'Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD', 'organization': {'class': 'OTHER', 'fullName': 'Springfield College'}, 'officialTitle': 'Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients', 'orgStudyIdInfo': {'id': 'Prebiotic study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Resistant Starch', 'description': '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', 'interventionNames': ['Dietary Supplement: Resistant starch']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise & Resistant Starch', 'description': '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', 'interventionNames': ['Dietary Supplement: Resistant starch', 'Behavioral: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Starch', 'description': 'Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks', 'interventionNames': ['Behavioral: Starch']}], 'interventions': [{'name': 'Resistant starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion', 'armGroupLabels': ['Exercise & Resistant Starch', 'Resistant Starch']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity', 'armGroupLabels': ['Exercise', 'Exercise & Resistant Starch']}, {'name': 'Starch', 'type': 'BEHAVIORAL', 'description': 'Patients will be given 30 grams of corn starch', 'armGroupLabels': ['Starch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01109', 'city': 'Springfield', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel A Headley, Ph.D', 'role': 'CONTACT', 'email': 'sheadley@springfieldcollege.edu', 'phone': '413-748-3340', 'phoneExt': '3340'}, {'name': 'Samuel A Headley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael J Germain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Springfield College', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'centralContacts': [{'name': 'Samuel A Headley, PhD', 'role': 'CONTACT', 'email': 'sheadley@springfieldcollege.edu', 'phone': '413-748-3340'}, {'name': 'James Harnsberger, PhD', 'role': 'CONTACT', 'email': 'jharnsberger@springfieldcollege.edu', 'phone': '413-748-4826'}], 'overallOfficials': [{'name': 'Samuel A Headley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Springfield College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Springfield College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Exercise Science & Sport Studies', 'investigatorFullName': 'Samuel A. Headley', 'investigatorAffiliation': 'Springfield College'}}}}