Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 8:39 PM
Study NCT ID:
NCT03374150
Status:
UNKNOWN
Last Update Posted:
2017-12-15
First Post:
2017-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D000091622', 'term': 'Weight Cycling'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D015431', 'term': 'Weight Loss'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2017-12-03', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': 'eight weeks', 'description': 'body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit'}, {'measure': 'body mass index', 'timeFrame': 'eight weeks', 'description': "a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram per meter squared (kg/m\\^2) unit"}, {'measure': 'fat mass', 'timeFrame': 'eight weeks', 'description': "actual weight of fat in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit"}, {'measure': 'fat mass percentage', 'timeFrame': 'eight weeks', 'description': 'the proportion of fat to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed as percentage (%)'}, {'measure': 'muscle mass', 'timeFrame': 'eight weeks', 'description': "The predicted weight of muscle in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit"}, {'measure': 'muscle mass percentage', 'timeFrame': 'eight weeks', 'description': 'The predicted proportion of muscle weight to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit'}, {'measure': 'Inflammation marker (high-sensitivity C-reactive protein)', 'timeFrame': 'eight weeks', 'description': 'indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device'}, {'measure': 'plasma malondialdehyde level', 'timeFrame': 'eight weeks', 'description': "the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit"}, {'measure': 'plasma gluthatione level', 'timeFrame': 'eight weeks', 'description': "the concentration of glutathione ((2S)-2-Amino-4-{\\[(1R)-1-\\[(carboxymethyl)carbamoyl\\]-2-sulfanylethyl\\]carbamoyl}butanoic acid) as an endogenous antioxidant compound in the plasma measured by means of Ellman's method expressed in µg/ml plasma unit"}], 'secondaryOutcomes': [{'measure': 'days of compliance', 'timeFrame': 'eight weeks', 'description': 'the number of day in which a participant adhere to the assigned dietary plan'}, {'measure': 'mean caloric intake', 'timeFrame': 'eight weeks', 'description': 'the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie'}, {'measure': 'mean percentage of caloric intake from protein', 'timeFrame': 'eight weeks', 'description': 'the average proportion of calories obtained from protein compared to the overall daily caloric intake expressed as percentage (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-Calorie Diet', 'Diet, High-Protein', 'Obesity', 'weight cycling', 'body composition', 'high-sensitivity C-Reactive protein', 'malondialdehyde', 'glutathione'], 'conditions': ['Low-Calorie Diet', 'Diet, High-Protein', 'Obesity; Pituitary', 'Weight Cycling']}, 'referencesModule': {'references': [{'pmid': '30241565', 'type': 'DERIVED', 'citation': 'Witjaksono F, Jutamulia J, Annisa NG, Prasetya SI, Nurwidya F. Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling. BMC Res Notes. 2018 Sep 21;11(1):674. doi: 10.1186/s13104-018-3781-z.'}]}, 'descriptionModule': {'briefSummary': 'The world prevalence of obesity in adult population in 2014 was nearly 13% while in Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for cardiovascular diseases. A large proportion of people who had succeeded to reduce body weight failed to maintain it (weight cycling). Studies were inconclusive about the best composition in the diet for such people to have a better life quality and reduce risk factors from non-communicable disease. The purpose of this research was to evaluate the body composition changes, Inflammation marker and oxidative stress marker changes resulted from low calorie high protein and standard protein diet programme in obese people with history of weight cycling.\n\nThis is an open-randomized clinical trial of weight loss program as a part of a larger study researching the effect of low calorie high protein diet to body composition, oxidative stress, inflammation marker and metabolic syndrome in obese with weight cycling. Subjects were assigned to low calorie diet and were randomly distributed into two intervention groups, namely high protein group (22-30 % of total calories intake) and standard protein group (12-20%). Anthropometry, body composition data, and blood sample (for inflammation marker (HsCRP) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at the end of the study. Subjects were followed up to 8 weeks with daily reminder and weekly counselling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index ranging from 25 - 35 kg/m2\n* history of weight loss ≥2 kg and regaining weight into or exceeding its initial body weight at least twice in last five years\n\nExclusion Criteria:\n\n* diabetes mellitus\n* history of gastrointestinal tract resection\n* hormonal disorders\n* using hormonal contraception\n* menopause,\n* kidney function disruption'}, 'identificationModule': {'nctId': 'NCT03374150', 'briefTitle': 'The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition (Weight, Body Mass Index, Fat Mass (kg), Fat Mass Percentage, Muscle Mass (kg), Muscle Mass Percentage, Inflammation Marker (High-sensitivity C-reactive Protein), and Oxidative Stress Marker (Malondialdehyde and Glutathione) in Obese People With Weight Cycling in Jakarta', 'orgStudyIdInfo': {'id': 'PITTAgizi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high protein', 'description': 'High protein (HP) group were given counseling about weight loss program by applying low calorie-high protein diet with diet menu composition of 22-30% protein, along with instructions for allowed cooking method.', 'interventionNames': ['Behavioral: diet counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard protein', 'description': 'Active comparator receiving standard protein (SP) proportion were counseled about weight loss program by means of low calorie-balanced composition diet with menu comprised of 12-20% protein.', 'interventionNames': ['Behavioral: diet counseling']}], 'interventions': [{'name': 'diet counseling', 'type': 'BEHAVIORAL', 'description': "Subjects were given nutrition consultation, diet recipes, and logbook. Counseling was performed once weekly. During 8 weeks of diet program, subjects were instructed to reduce their daily caloric intake by 500 - 1000 kcal from their previous usual daily intake with limitation in low calorie diet range (800-1500 kcal.day) of calorie intake.Follow-up for each subject was performed once daily by person-to-person encounter. Besides, subjects were contacted by everyday cellphone texting and telephone twice a week to control subject's compliance. After 8 weeks of intervention, subjects were invited to revisit the clinic for anthropometry and body composition measurement after completing the program.", 'armGroupLabels': ['high protein', 'standard protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10110', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': "Civil Workers' Health Service Center of Special Capital Region", 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Pusat', 'country': 'Indonesia', 'facility': 'Seruni Nutrition Clinic', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invdstigator', 'investigatorFullName': 'Fiastuti Witjaksono', 'investigatorAffiliation': 'Indonesia University'}}}}