Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-06 @ 7:04 PM
Study NCT ID:
NCT03232034
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium, Protein and Gut Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019355', 'term': 'Calcium Citrate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants and Researchers will be blinded to the interventions.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-26', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).', 'timeFrame': '120 min', 'description': 'Plasma glucagon-like peptide-1 (GLP-1) concentrations'}], 'secondaryOutcomes': [{'measure': 'Postprandial plasma GIP area under the curve (mmol/L x 120 min)', 'timeFrame': '120 min', 'description': 'Plasma glucose-dependent insulinotropic peptide (GIP) concentrations'}, {'measure': 'Postprandial plasma PYY area under the curve (mmol/L x 120 min)', 'timeFrame': '120 min', 'description': 'Plasma peptide tyrosine tyrosine (PYY) concentrations.'}, {'measure': 'Subjective ratings of appetite (au)', 'timeFrame': '120 min', 'description': 'Visual analogue scales of appetite ratings'}, {'measure': 'Energy metabolism (carbohydrate and fat oxidation)', 'timeFrame': '120 min', 'description': 'Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry'}, {'measure': 'Postprandial plasma glucose', 'timeFrame': '120 min', 'description': 'Plasma glucose concentrations (mmol/L).'}, {'measure': 'Blood pressure', 'timeFrame': '120 min', 'description': 'Systolic and diastolic blood pressure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcium citrate, dairy product, whey protein, appetite, metabolism'], 'conditions': ['Obesity', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '31531707', 'type': 'DERIVED', 'citation': 'Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.', 'detailedDescription': 'Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).\n\nBlood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women age between 18-65 yrs.\n* Able to consume provided supplement.\n* Weigh stable for the past 3 month (no change within 3%).\n\nExclusion Criteria:\n\n* Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease\n* Not between the ages of 18-65 years\n* A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)\n* Taking medications that may influence your metabolism\n* Plans to change your lifestyle (diet and/or physical activity) during the study period\n* Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.\n* Current smoker'}, 'identificationModule': {'nctId': 'NCT03232034', 'briefTitle': 'Calcium, Protein and Gut Hormones', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion', 'orgStudyIdInfo': {'id': 'REACH EP 16/17_164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Calcium Citrate', 'description': 'Calcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.', 'interventionNames': ['Dietary Supplement: Calcium Citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Milk Mineral Supplement', 'description': 'Milk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.', 'interventionNames': ['Dietary Supplement: Milk Mineral Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Milk mineral supplement plus Whey Protein Hydrolysate', 'description': 'Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.', 'interventionNames': ['Dietary Supplement: Milk Mineral Supplement', 'Dietary Supplement: Whey Protein Hydrolysate']}], 'interventions': [{'name': 'Calcium Citrate', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg calcium as calcium citrate', 'armGroupLabels': ['Calcium Citrate']}, {'name': 'Milk Mineral Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Milk Minerals containing 1000 mg calcium', 'armGroupLabels': ['Milk Mineral Supplement', 'Milk mineral supplement plus Whey Protein Hydrolysate']}, {'name': 'Whey Protein Hydrolysate', 'type': 'DIETARY_SUPPLEMENT', 'description': '50 g whey protein hydrolysate', 'armGroupLabels': ['Milk mineral supplement plus Whey Protein Hydrolysate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bath', 'country': 'United Kingdom', 'facility': 'University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer (Assistant Professor) in Human Physiology', 'investigatorFullName': 'Javier Gonzalez', 'investigatorAffiliation': 'University of Bath'}}}}