Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
Study NCT ID:
NCT07298135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Open-Label, Controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects on Fasting Plasma Glucose', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in fasting plasma glucose'}], 'secondaryOutcomes': [{'measure': 'Effects on Long-term Glycemic Control', 'timeFrame': 'Baseline to week 8', 'description': 'Change in HbA1c'}, {'measure': 'Effect on insulin sensitivity', 'timeFrame': 'Baseline to week 8', 'description': 'Change in fasting plasma insulin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Glucose Control']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the chronic effects of replacing traditional non-diet soda with a prebiotic soda on biomarkers associated with glycemic control in adults with glucose dysregulation who are habitual consumers of traditional soda.', 'detailedDescription': 'The primary aim of this clinical trial is to evaluate the effects of replacing traditional non-diet soda with a prebiotic soda (i.e., OLIPOP) over an 8 week period on markers of glucose (blood sugar) control in adults with glucose (blood sugar) dysregulation.\n\nParticipants (n=224) will be habitual consumers of traditional non-diet sodas, consuming on average 2-3 servings of non-diet soda daily. Participants will be randomized to either an active control group (continued habitual traditional non-diet soda intake, 2 - 3 servings/day) or a behavioral intervention group (OLIPOP prebiotic soda, 2 cans/day, 6 g dietary fiber and 2 - 5 g total sugar per can).\n\nSecondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of metabolic health, including long-term glycemic control and insulin sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide informed consent\n* Willing to comply with all study procedures\n* Ages 40 - 70 years old\n* Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings/daily)\n* BMI between 25 - 35 kg/m²\n* Waist-to-Hip ratio ≥0.85 for Women and ≥0.9 for Men\n* Fasting plasma glucose between 100 - 125 mg/dL\n* Consumes ≤16 g total fiber per day to align with the current average dietary fiber intake of American adults\n* Non-user or former user (cessation ≥ 12 months) of tobacco or nicotine products\n* Non-user of marijuana and hemp products, including CBD products, in the previous 60 days\n* Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial\n\nExclusion Criteria:\n\n* Inability to consume a standard 12 fl. oz. carbonated beverage twice daily\n* Currently engaged or planning to be on an intensive weight loss regimen program\n* Extreme dietary habits or has been diagnosed with an eating disorder\n* Habitual use of fiber supplements, inulin-based supplements, acacia fiber, glucomannan, prebiotic supplements, or probiotic supplements within the previous 30 days\n* Known allergy or sensitivity to any of the ingredients in the study products\n* History or presence of uncontrolled and/or clinically important medical conditions that could interfere with study results interpretation (ex. uncontrolled diabetes mellitus, CKD stage 4-5, severe liver disease/cirrhosis, uncontrolled hypertension, recent myocardial infarction or stroke (within 6 months), severe mental illness or cognitive impairment, immunodeficiency disorders, active infections).\n* Gastrointestinal conditions that could potentially interfere with absorption of the study product\n* Use of oral or injectable steroids in the previous 90 days\n* Use of antibiotic therapy in the previous 90 days\n* Unstable use of prescription medications within the previous 90 days that affect plasma glucose levels\n* History or presence of cancer, except non-melanoma skin cancer, in the previous 2 years\n* Exposure to any non-registered drug product or participation in another intervention study in the previous 30 days\n* Recent history (within 12 months) of alcohol or substance abuse\n* History of major trauma or surgical event in the previous 60 days\n* Person who is pregnant, planning pregnancy, lactating, or unwilling to use contraception during the study period\n* Any condition the Investigator believes would interfere with study participation or compliance\n* Consumption of pre-biotic sodas in the previous 30 days'}, 'identificationModule': {'nctId': 'NCT07298135', 'briefTitle': 'A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olipop, PBC'}, 'officialTitle': 'A Randomized, Open-Label, Controlled Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults With Glucose Dysregulation', 'orgStudyIdInfo': {'id': '20254308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will be randomized to replace traditional non-diet soda with prebiotic soda', 'interventionNames': ['Behavioral: Prebiotic Soda']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants will be randomized to continue consumption of traditional non-diet soda.', 'interventionNames': ['Behavioral: Active Control']}], 'interventions': [{'name': 'Prebiotic Soda', 'type': 'BEHAVIORAL', 'description': 'Participants will replace traditional non-diet sodas in their diet with a prebiotic soda (OLIPOP). Participants will consume 2 cans/day (24 fl. oz/day) that will add 12 g dietary fiber/day to their diet.', 'armGroupLabels': ['Intervention']}, {'name': 'Active Control', 'type': 'BEHAVIORAL', 'description': 'Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Courtney McCormick, MPH, RDN, LDN', 'role': 'CONTACT', 'email': 'cmccormick@drinkolipop.com', 'phone': '18145719644'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olipop, PBC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Lindus Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}