Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-19 @ 10:35 AM
Study NCT ID:
NCT02887950
Status:
TERMINATED
Last Update Posted:
2025-05-01
First Post:
2016-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'whyStopped': 'No benefit at iterim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '3 months', 'description': 'Difference in change in body weight between patients receiving the experimental product and those not assigned to its use'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '6 months', 'description': 'Difference in change in body weight between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'Insulin resistance', 'timeFrame': '3 months', 'description': 'Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'LDL cholesterol', 'timeFrame': '3 months', 'description': 'Difference in change in LDL cholesterol between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'Triglycerides', 'timeFrame': '3 months', 'description': 'Difference in change in triglycerides between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'Insulin resistance', 'timeFrame': '6 months', 'description': 'Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'LDL cholesterol', 'timeFrame': '6 months', 'description': 'Difference in change in LDL cholesterol between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'Triglycerides', 'timeFrame': '6 months', 'description': 'Difference in change in triglycerides between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'Visceral adiposity', 'timeFrame': '3 months', 'description': 'Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'Visceral adiposity', 'timeFrame': '6 months', 'description': 'Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'Fat free mass', 'timeFrame': '3 months', 'description': 'Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'Fat free mass', 'timeFrame': '6 months', 'description': 'Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'Menopausal symptoms', 'timeFrame': '3 months', 'description': 'Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'Menopausal symptoms', 'timeFrame': '6 months', 'description': 'Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}, {'measure': 'Quality of life', 'timeFrame': '3 months', 'description': 'Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product and those not assigned to its use'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight']}, 'descriptionModule': {'briefSummary': 'For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus, hypertension and cardiovascular disease), and several studies have shown that the transition to menopause is associated with adverse changes in body composition. In particular, it is common to observe the accumulation of adipose tissue in the abdominal region which is believed to be an important determinant of the increase in cardiovascular risk.\n\nThe first-line strategy for weight management in overweight / obese subjects is the modification of dietary habits and lifestyle in terms of physical activity. However, nowadays, there is also a growing interest in complementary therapies (i.e. herbal supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and chlorogenic acid as adjuvants of dietary therapy for overweight.\n\nThese nutrients may be an important therapeutic aid for overweight subjects. However, in support of their use, the evidence from good quality trials is limited.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* menopause of recent onset\n* overweight (body mass index ≥ 25) or weight gain ≥ 10% after menopause\n* written informed consent\n\nExclusion Criteria:\n\n* use of Orlistat\n* cancer diagnosis\n* unavailability to planned measurements'}, 'identificationModule': {'nctId': 'NCT02887950', 'briefTitle': 'Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.', 'orgStudyIdInfo': {'id': '20150021742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nutritional counseling', 'description': "Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.", 'interventionNames': ['Other: Nutritional counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Equikilon-3 months', 'description': "The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.\n\nNutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.", 'interventionNames': ['Dietary Supplement: Equikilon-3 months']}, {'type': 'EXPERIMENTAL', 'label': 'Equikilon-6 months', 'description': "The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.\n\nNutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.", 'interventionNames': ['Dietary Supplement: Equikilon-6 months']}], 'interventions': [{'name': 'Nutritional counseling', 'type': 'OTHER', 'description': "Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.", 'armGroupLabels': ['Nutritional counseling']}, {'name': 'Equikilon-3 months', 'type': 'DIETARY_SUPPLEMENT', 'description': "The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.\n\nNutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.", 'armGroupLabels': ['Equikilon-3 months']}, {'name': 'Equikilon-6 months', 'type': 'DIETARY_SUPPLEMENT', 'description': "The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.\n\nNutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.", 'armGroupLabels': ['Equikilon-6 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Riccardo Caccialanza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leonardo Medica Srl', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Riccardo Caccialanza', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}