Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04347304
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese Adults Using Metabolomics Approach
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059808', 'term': 'Polyphenols'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, open-labelled, parallel controlled trial will be conducted in Universiti Putra Malaysia from October 2021 until December 2022 involving obese adult aged 18 - 45 years.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in insulin resistance at 12 week', 'timeFrame': 'baseline and 8 weeks', 'description': 'Insulin resistance will be determined HOMA-IR and calculated as HOMA-IR = fasting serum x fasting blood glucose/22.5.'}, {'measure': 'change in insulin sensitivity at 8 weeks', 'timeFrame': 'baseline and 8 weeks', 'description': 'To assess insulin sensitivity, Quantitative Insulin Sensitivity Check Index (QUICKI) will be used and cutt off point of less than 0.33 indicates reduced insulin sensitivity'}], 'secondaryOutcomes': [{'measure': 'change in body weight at 8 weeks', 'timeFrame': 'baseline and 8 weeks', 'description': 'Body weight will be measured in kilograms using SECA electronic scale model 703.'}, {'measure': 'change in waist circumference at 8 weeks', 'timeFrame': 'baseline and 8 weeks', 'description': 'Waist circumference will be assessed at the midpoint between the lowest rib andd the iliac crest using a non-stretchable tape measure. The measurement will be conducted twice to the nearest 0.1cm. The cutoff points for waist ciircumference by WHO expert committee on obesity in Asian and Pacific populations are \\>90 cm for men and \\>80cm fro women.'}, {'measure': 'change in lipid profiles (TG, HDL-c, LDL-c, TC) at 8 weeks', 'timeFrame': 'baseline and 8 weeks', 'description': 'Lipid profiles (TG, Cholesterol, LDL-c, and HDL-c) will be determined using commercially available kits using Architect ci8200 analyzer'}, {'measure': 'change in inflammatory markers (C-reactive protein ) at 8 week', 'timeFrame': 'baseline and 8 weeks', 'description': 'C-reactive protein will be measured using kits of human inflammatory cytokines by Enzyme Linked Inmuno Sorbent Assay from blood serum and will be expressed as mg/L.'}, {'measure': 'change in oxidative stress markers (oxidized LDL) at 8 week', 'timeFrame': 'baseline and 8 weeks', 'description': 'Levels of LDL-ox in plasma will be analysed at the beginning and the end (8 weeks) and will be expressed as mg/L.'}, {'measure': 'changes in metabolomics profiles following flavanol-rich dark chocolate consumption at 8 week', 'timeFrame': 'baseline and 8 weeks', 'description': 'Metabolomic analysis of the plasma sample will be performed using 1H-NMR platform'}, {'measure': 'changes in gut microbiome status following flavanol-rich dark chocolate consumption at 8 week', 'timeFrame': 'baseline and 8 weeks', 'description': 'metagenomic analysis of fecal samples will be analysed at the beginning and end (8 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Cocoa polyphenols', 'Dark chocolate'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23088297', 'type': 'BACKGROUND', 'citation': 'Moazzami AA, Bondia-Pons I, Hanhineva K, Juntunen K, Antl N, Poutanen K, Mykkanen H. Metabolomics reveals the metabolic shifts following an intervention with rye bread in postmenopausal women--a randomized control trial. Nutr J. 2012 Oct 22;11:88. doi: 10.1186/1475-2891-11-88.'}, {'pmid': '10927169', 'type': 'BACKGROUND', 'citation': 'Hensley K, Robinson KA, Gabbita SP, Salsman S, Floyd RA. Reactive oxygen species, cell signaling, and cell injury. Free Radic Biol Med. 2000 May 15;28(10):1456-62. doi: 10.1016/s0891-5849(00)00252-5.'}, {'pmid': '21085649', 'type': 'BACKGROUND', 'citation': 'Suhre K, Meisinger C, Doring A, Altmaier E, Belcredi P, Gieger C, Chang D, Milburn MV, Gall WE, Weinberger KM, Mewes HW, Hrabe de Angelis M, Wichmann HE, Kronenberg F, Adamski J, Illig T. Metabolic footprint of diabetes: a multiplatform metabolomics study in an epidemiological setting. PLoS One. 2010 Nov 11;5(11):e13953. doi: 10.1371/journal.pone.0013953.'}]}, 'descriptionModule': {'briefSummary': 'Obesity has become a global issue due to its alarming high and increasing prevalence worldwide and the roles it plays in occurrence of many chronic diseases. In addition, obesity is characterized as a state of chronic, low-grade inflammation and is associated with an abnormal inflammatory response, low antioxidant capacity and reduced insulin sensitivity which lead to the generation of inflammation, oxidative stress and insulin resistance.\n\nAs in Malaysia, study by National Health and Morbidity Survey Malaysia (NHMS) in 2011 and 2015 showed a continuing increase of the problem. In response to the rise of obesity prevalence, various efforts and strategies have been implemented in the past decade to combat this problem. The use of natural products as therapeutic agents in preventing metabolic disease has becoming popular. Cocoa and its products is a largely consumed food in the world. It has a very rich sources of phenolic compound. Several in vitro and in vivo studies have shown that polyphenols, with antioxidant, anti-inflammatory and anti-obesity properties, can boost energy expenditure and thermogenesis, lessen oxidative stress and inflammation while supporting weight loss management. Furthermore, the contribution of human studies especially among obese relatively limited.\n\nThe popularity of chocolate and/or cocoa and its frequent consumption made it the target of many research studies, due to its favourable effects, and to the significant role it may exert on improving the obesity condition. Therefore, this study aims to investigate the effects of flavanol-rich dark chocolate consumption on metabolic profiles of obese adults using metabolomic approach.', 'detailedDescription': 'Overnutrition and sedentary lifestyle are the leading factors associated with the development of obesity. Obese adults usually are advised to make lifestyle modifications which include dietary restriction and physical activity recommendation. In addition, dietary supplements and medication such as anti-hypertensive, lipid lowering drugs are used to achieved targeted body weight of obese adult. Therefore, the confounding factors in this study namely dietary intake, physical activity, medication, supplements were controlled throughout the study. These factors including smoking were also controlled as it will affect the metabolites.\n\nImbalance between energy intake and expenditure results in adipose tissue expansion due to excessive lipogenesis in adipose tissues. Generally, it is well accepted that adipose tissue expansion in an obese state is accompanied by elevated inflammation. Oxidative stress and pro-inflammatory processes are strongly related. Increased abdominal adipose tissue accelerates the production of pro-inflammatory cytokines which promote increased generation of ROS, both inflammation and oxidative stress play a significant role in the development of insulin resistant thus further are associated with the degree of metabolic dysfunction.\n\nIt was hypothesized that cocoa flavanol with the properties of anti-inflammation, anti-oxidative and antiobesity properties may reduce the oxidative stress and inflammation, subsequently reduce the insulin resistance and thus improved the outcome measurements in obese adult. In order to measures the altered metabolite in the urine and blood serum following cocoa rich flavanol consumption in dark chocolate in obese adult, a metabolomics based approach is used in this study.\n\nThis study is a randomized, open-labelled, parallel controlled trial where the intervention group will receive 20 grams of dark chocolate, daily for 12 weeks while the control group will receive 20 grams of white chocolate daily for 12 weeks. Measurement will be taken including sociodemographic, anthropometric measurement, diet and physical activity questionnaire, blood and urine samples at baseline and 12 weeks of intervention. Obese male adult aged 18-45 years old will be recruited'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malaysian\n* Obese BMI ≥ 25.0 kg/m2\n* Not on any drug or herbal preparation, antioxidative or any drugs or dietary supplement.\n* Do not have any chronic diseases\n* Do not have allergy to cocoa\n* Age 18-45 years old.\n\nExclusion Criteria:\n\n* Non-Malaysian\n* BMI \\< 25.0 kg/m2\n* Smokers and alcohol drinkers\n* Participants with cardiovascular diseases, hypertension or diabetes\n* Participants taking medications that affect insulin, glucose, lipid or blood pressure levels\n* Participants taking any dietary supplements\n* Have allergy towards cocoa beverages\n* Participants who are currently involved in a weight management program'}, 'identificationModule': {'nctId': 'NCT04347304', 'briefTitle': 'Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese Adults Using Metabolomics Approach', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': 'Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese', 'orgStudyIdInfo': {'id': 'NMRR-19-3092-51617.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cocoa polyphenols', 'description': '21 grams of dark chocolate (289 mg polyphenols)', 'interventionNames': ['Dietary Supplement: Dark chocolate (20 grams) per day providing 508 mg of polyphenols']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'polyphenols free', 'description': '21 grams of white chocolate (0 mg polyphenols)', 'interventionNames': ['Dietary Supplement: white chocolate (20 grams) with no polyphenols']}], 'interventions': [{'name': 'Dark chocolate (20 grams) per day providing 508 mg of polyphenols', 'type': 'DIETARY_SUPPLEMENT', 'description': 'subjects will be given 21 grams of dark chocolate providing 289 mg of polyphenols per day for 12 weeks.', 'armGroupLabels': ['cocoa polyphenols']}, {'name': 'white chocolate (20 grams) with no polyphenols', 'type': 'DIETARY_SUPPLEMENT', 'description': 'subjects will be given 21 grams of white chocolate (0 mg polyohenols) per day for 12 weeks', 'armGroupLabels': ['polyphenols free']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43400', 'city': 'Seri Kembangan', 'state': 'Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Zulfitri Azuan Mat Daud, PhD', 'role': 'CONTACT', 'email': 'zulfitri@upm.edu.my', 'phone': '60397692431'}], 'facility': 'Universiti Putra Malaysia', 'geoPoint': {'lat': 3.03333, 'lon': 101.71667}}], 'centralContacts': [{'name': 'Zulfitri Azuan Mat Daud, PhD', 'role': 'CONTACT', 'email': 'zulfitri@upm.edu.my', 'phone': '+60397692431'}], 'overallOfficials': [{'name': 'Amin Ismail, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Putra Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Hasmiza Halib', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}