Nctid:
NCT06221696
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000050177", "term"=>"Overweight"}], "ancestors"=>[{"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M26186", "name"=>"Overweight", "asFound"=>"Overweight", "relevance"=>"HIGH"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M353561", "name"=>"Semaglutide", "relevance"=>"LOW"}, {"id"=>"M14475", "name"=>"Psyllium", "relevance"=>"LOW"}, {"id"=>"M244425", "name"=>"Calcium polycarbophil", "relevance"=>"LOW"}, {"id"=>"M342442", "name"=>"(1-6)-alpha-glucomannan", "relevance"=>"LOW"}, {"id"=>"T401", "name"=>"Inulin", "relevance"=>"LOW"}, {"id"=>"T262", "name"=>"Psyllium", "relevance"=>"LOW"}, {"id"=>"T223", "name"=>"Manna", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>160}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-06-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-12-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-02-09", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-11-23", "type"=>"ACTUAL"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Fasting and mean postprandial changes in visual analog score (VAS) ratings from 0 to 10 points for thirst, nausea, and well-being following a standardized breakfast.", "timeFrame"=>"180 days"}, {"measure"=>"Participant-reported control of eating evaluated using the Control of Eating Questionnaire (CoEQ) with 20 questions containing 5 oprions where 1 means the best and 5 the worst outcome", "timeFrame"=>"180 days"}], "primaryOutcomes"=>[{"measure"=>"Percentage of weight regain from baseline", "timeFrame"=>"180 days"}], "secondaryOutcomes"=>[{"measure"=>"blood glucose levels change", "timeFrame"=>"180 days"}, {"measure"=>"blood HbA1c change", "timeFrame"=>"180 days"}, {"measure"=>"blood total cholesterol change", "timeFrame"=>"180 days"}, {"measure"=>"blood LDL change", "timeFrame"=>"180 days"}, {"measure"=>"blood triglycerides change", "timeFrame"=>"180 days"}, {"measure"=>"Systolic and diastolic blood pressure change", "timeFrame"=>"180 days"}, {"measure"=>"BMI changes", "timeFrame"=>"180 days", "description"=>"Monitoring the changes in Body Mass Index from the baseline"}, {"measure"=>"Visceral fat rating change from baseline", "timeFrame"=>"180 days"}, {"measure"=>"fat-free mass changes", "timeFrame"=>"180 days"}, {"measure"=>"visceral fat changes", "timeFrame"=>"180 days"}, {"measure"=>"total body water changes", "timeFrame"=>"180 days"}, {"measure"=>"Effect of glucomannan, inulin, and psyllium on appetite assessed using mean postprandial participant-reported visual analog score (VAS) ratings from 0 to 10 points, where 0 is appetite absence and 10 good appetite, following a standardized breakfast", "timeFrame"=>"180 days"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Semaglutide", "Dietary Fiber", "Weight Loss", "Appetite Suppression"], "conditions"=>["Overweight and Obesity"]}, "descriptionModule"=>{"briefSummary"=>"This randomized, double-blind, placebo-controlled trial titled \"Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)\" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adults with a history of obesity or overweight and completed Semaglutide course.\n* Age 18-65 years.-\n\nExclusion Criteria:\n\n* Serious chronic illnesses.\n* History of bulimia or anorexia.\n* Pregnancy or lactation."}, "identificationModule"=>{"nctId"=>"NCT06221696", "acronym"=>"PWR-FAST", "briefTitle"=>"Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)", "organization"=>{"class"=>"OTHER", "fullName"=>"S.LAB (SOLOWAYS)"}, "officialTitle"=>"Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial", "orgStudyIdInfo"=>{"id"=>"SW005"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Active Fiber Supplement Group", "interventionNames"=>["Dietary Supplement: Active Fiber Supplement Group"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo Group", "interventionNames"=>["Other: Placebo Group"]}], "interventions"=>[{"name"=>"Active Fiber Supplement Group", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Three daily packets of active fiber supplement (each containing 1g of glucomannan, 1g of inulin, and 3g of psyllium), taken 30 minutes before each main meal. The supplement is provided by S.Lab (Soloways), LLC.", "armGroupLabels"=>["Active Fiber Supplement Group"]}, {"name"=>"Placebo Group", "type"=>"OTHER", "description"=>"Three daily packets of placebo powder, taken 30 minutes before each main meal.", "armGroupLabels"=>["Placebo Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"630090", "city"=>"Novosibirsk", "state"=>"Novosibisk Region", "country"=>"Russian Federation", "facility"=>"Center of New Medical Technologies", "geoPoint"=>{"lat"=>55.0415, "lon"=>82.9346}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"S.LAB (SOLOWAYS)", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Center of New Medical Technologies", "class"=>"OTHER"}, {"name"=>"Triangel Scientific", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
