Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04695418
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of body composition', 'timeFrame': 'Baseline and 4 weeks', 'description': 'free fat mass (g), fat mass (g), visceral abdominal tissue (g)'}], 'secondaryOutcomes': [{'measure': 'Change of amino acid profiles', 'timeFrame': 'Baseline and 4 weeks', 'description': 'aspartic acid, glutamic acid, alanine, arginine, asparagine, cysteine, citrulline, phenylalanine, glycine, glutamine, isoleucine, histidine, methylhistidine, methionine, ornithine, serine, tyrosine, threonine, tryptophan, valine (micromol/L)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'total serum cholesterol, triacylglycerol, HDL-cholesterol, LDL-cholesterol, apolipoprotein A, apolipoprotein B, glucose, prealbumin, iron, uric acid, creatinine, electrolytes (mg/dl)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'total proteins (g/dl)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'transaminase alanine aminotransferase, aspartate aminotransferase (IU/L)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'gamma glutamyl transferase, lipase and amylase (U/L)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Homocysteine (micromol/L)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Vitamin D and folic acid (ng/mL)'}, {'measure': 'Change of biochemical metabolic parameters', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Vitamin B12 (pg/ml)'}, {'measure': 'Change of inflammation markers', 'timeFrame': 'Baseline and 4 weeks', 'description': 'C- Reactive protein (mg/dl)'}, {'measure': 'Change of insulin resistance', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Homeostasis Model Assessment (HOMA) index'}, {'measure': 'Change of satiating capacity', 'timeFrame': 'Every day for 4 weeks', 'description': 'Haber score (point scale)'}, {'measure': 'Change of anthropometric measures', 'timeFrame': 'Baseline and 4 weeks', 'description': 'weight (kg)'}, {'measure': 'Change of anthropometric measures', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Body mass index (Kg/m2)'}, {'measure': 'Change of anthropometric measures', 'timeFrame': 'Baseline and 4 weeks', 'description': 'calf circumference, waist circumference, arm circumference, hip circumference (cm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rice Germ', 'Body composition', 'Amino acids'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p\\<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity (BMI 30-40 kg/m2)\n* age 50-65\n* menopause\n* sedentary women and non-smoking,\n* women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)\n* women who agreed not to take part in any other weight loss program\n\nExclusion Criteria:\n\n* evidence of heart, kidney or liver disease\n* women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder\n* taking any medications for weight loss\n* control of cholesterol and triglycerides for anti-inflammatory purposes\n* pregnancy\n* lactating\n* Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis\n* antibiotic use in the last three months\n* probiotic/prebiotic treatment in the last four weeks.'}, 'identificationModule': {'nctId': 'NCT04695418', 'briefTitle': 'Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '1402/22052019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'an isocaloric wheat germ-based supplement', 'interventionNames': ['Combination Product: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rice Germ', 'interventionNames': ['Dietary Supplement: Rice Germ']}], 'interventions': [{'name': 'Rice Germ', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks', 'armGroupLabels': ['Rice Germ']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Azienda di Servizi alla Persona', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}