Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT04458493
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in body weight', 'timeFrame': '1 day prior to the start of the experiment and on the 31st day of the experiment', 'description': 'body weight will be measured using a scale at home prior to breakfast'}], 'secondaryOutcomes': [{'measure': 'changes in waist and hip circumferences', 'timeFrame': '1 day prior to the start of the experiment and on the 31st day of the experiment', 'description': 'waist and hip circumferences will be measured using a measuring tape at home prior to breakfast'}, {'measure': 'changes in fasted blood glucose', 'timeFrame': '1 day prior to the start of the experiment and on the 31st day of the experiment', 'description': 'blood glucose will be measured through finger pricks'}, {'measure': 'changes in appetite ratings', 'timeFrame': '30, 60 and 120 minutes after each meal replacement drink', 'description': 'appetite ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being strong desire to consume food and 1 being no desire to consume food at all'}, {'measure': 'changes in desire to eat ratings', 'timeFrame': '30, 60 and 120 minutes after each meal replacement drink', 'description': 'desire to eat ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being no desire to eat at all and 1 being strong desire to eat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'Participants will be randomized into two groups, one group will be the control (no intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first day of the experiment, all participants will be asked to measure their waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast. Instructions on how to do the measurements properly will be recorded in a video and distributed to the participants. Participants in the control group will not receive any intervention. Participants in the CHO-PRO group will be provided with the supplement and they will be asked to consume the CHO - protein supplement (Generation UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for 6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink. All participants will be required to complete a dietary record, prior to, and during (at weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be asked to check off the calendar that they did not consume the meal replacement due to various reasons. On day 43, all participants will be asked measure again waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sedentary (\\<2 moderate exercise bouts/wk)\n* between the ages of 18 to 40y\n* body mass index (BMI) between \\>25\n\nExclusion Criteria:\n\n* do not eat three meals a day typically\n* taking medication that affects their eating patterns\n* have metabolic and gastrointestinal diseases'}, 'identificationModule': {'nctId': 'NCT04458493', 'briefTitle': 'Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?', 'orgStudyIdInfo': {'id': '116302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'no supplement will be provided on the day of the experiment', 'interventionNames': ['Behavioral: satiety']}, {'type': 'EXPERIMENTAL', 'label': 'Generation UCAN', 'description': 'carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)', 'interventionNames': ['Behavioral: satiety', 'Dietary Supplement: Dietary Supplement: Generation UCAN supplementation']}], 'interventions': [{'name': 'satiety', 'type': 'BEHAVIORAL', 'description': 'satiety ratings, appetite and desire to eat (10-point visual analogue scale) will be measured at 30, 60 and 120 minutes after each meal replacement drink', 'armGroupLabels': ['Generation UCAN', 'control']}, {'name': 'Dietary Supplement: Generation UCAN supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'meal replacement, Generation UCAN supplement, 400ml, 20% solution', 'armGroupLabels': ['Generation UCAN']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Crystal Lee, BSc', 'role': 'CONTACT', 'email': 'plee263@uwo.ca', 'phone': '519 6612111'}, {'name': 'Manuel Manuel, MSc', 'role': 'CONTACT', 'email': 'mquinon2@uwo.ca', 'phone': '519 6612111'}], 'overallOfficials': [{'name': 'Peter Lemon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Lemon', 'investigatorAffiliation': 'Western University, Canada'}}}}