Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-29 @ 2:52 PM
Study NCT ID:
NCT02587156
Status:
COMPLETED
Last Update Posted:
2018-03-05
First Post:
2015-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fate of Nutrient-Derived Amino Acids, FONDAA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abundance of milk protein-bound amino acid labels in blood protein.', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nAfter intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in liver-synthesized blood protein at 240 min.'}], 'secondaryOutcomes': [{'measure': 'Abundance of milk protein-bound amino acid labels in myofibrillar protein.', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nAfter intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in myofibrillar protein at 240 min.'}, {'measure': 'Leg phenylalanine rate of disappearance and appearance, net balance.', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nFrom arterial and femoral venous blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments and concentrations as well as plasma flow will be measured.'}, {'measure': 'First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nFrom hepatic venous blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments and concentrations as well as plasma flow will be measured. Knowing the amount of ingested protein and labeled phenylalanine we can calculate the first pass splanchnic amino acid extraction.'}, {'measure': 'Whole body phenylalanine rate of disappearance and appearance, net balance.', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nFrom blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments will be measured.'}, {'measure': 'The myofibrillar protein fractional synthesis rate', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nFrom muscle biopsies obtained at baseline, 60 and 240 min the abundance of phenylalanine tracer bound in the myofibrillar proteins will be measured and the fractional synthesis rate will be measured within the first from baseline to 60 min and 240 min as well as from 60-240 min postprandial.'}, {'measure': 'Response of expression of proteins involved in muscle protein turnover', 'timeFrame': 'Baseline, 60 min and 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nFrom baseline to 60 and 240 min after intake of the standardized meal after 21 days of habituation to either a high or a low dietary protein intake expression of signalling proteins related to protein turnover in the muscle will be measured by use of western blotting.'}, {'measure': 'Urea production.', 'timeFrame': 'Baseline to 240 min postprandial', 'description': 'Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:\n\nFrom blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min urea tracer enrichments and concentrations will be measured. With this, and flow measurements, we can determine the rate of urea production.'}, {'measure': 'Nitrogen and creatinine excreted in urine', 'timeFrame': '21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day', 'description': 'Related to the adaptation to the 21 day habituation period to either high or low protein in the diet as well as the response to the standardized trial meal:\n\nNitrogen and creatinine content is measured in urine is collected for the last 24 h of the 21 day habituation period, as well as during the 240 min trial day and the remaining 20 hours of the trial day.'}, {'measure': 'Fecal microbiota composition', 'timeFrame': 'Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21)', 'description': 'Related to the adaptation to the 21 day habituation period to either high or low protein in the diet as well as the response to the standardized trial meal:\n\nThe microbiota compositions, will be measured in fecal samples collected before the 21 day habituation period, after the 21 day habituation periode, as well as after the 240 min trial day'}, {'measure': 'Adaptation of expression of proteins involved in muscle protein turnover', 'timeFrame': 'After 21 days of habituation to either a high or a low dietary protein intake.', 'description': 'Related to the adaptation to the 21 day habituation period to either high or low protein in the diet:\n\nBiopsies taken following the two 21 day habituation period will, by use of western blotting, be analysed for expression of signalling proteins involved in muscle protein turnover.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Required dietary protein', 'Amino acid', 'Splanchnic extraction'], 'conditions': ['Protein Utilization', 'Dietary Protein']}, 'referencesModule': {'references': [{'pmid': '32710741', 'type': 'DERIVED', 'citation': 'Hojfeldt G, Bulow J, Agergaard J, Asmar A, Schjerling P, Simonsen L, Bulow J, van Hall G, Holm L. Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Dec 10;112(6):1468-1484. doi: 10.1093/ajcn/nqaa201.'}]}, 'descriptionModule': {'briefSummary': '12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '65 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* Hyperlipidemia\n* Hypertension\n\nInclusion Criteria:\n\n* Males age 65-70\n* Independently dwelling\n* Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)\n* Non-diabetic\n* No organ disease\n* No back pain\n* Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis\n* Alcohol intake below 21 units pr. week\n* No known arthrosclerosis'}, 'identificationModule': {'nctId': 'NCT02587156', 'acronym': 'FONDAA', 'briefTitle': 'Fate of Nutrient-Derived Amino Acids, FONDAA', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization', 'orgStudyIdInfo': {'id': 'BBH122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal serving at high dietary protein', 'description': 'Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day', 'interventionNames': ['Dietary Supplement: Meal serving at high dietary protein', 'Dietary Supplement: Meal serving']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meal serving at low dietary protein', 'description': 'Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day', 'interventionNames': ['Dietary Supplement: Meal serving at low dietary protein', 'Dietary Supplement: Meal serving']}], 'interventions': [{'name': 'Meal serving at high dietary protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants are habituated to a high level of dietary protein intake for 21 days.', 'armGroupLabels': ['Meal serving at high dietary protein']}, {'name': 'Meal serving at low dietary protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants are habituated to a low level of dietary protein intake for 21 days.', 'armGroupLabels': ['Meal serving at low dietary protein']}, {'name': 'Meal serving', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To investigate impact of habituated protein level', 'armGroupLabels': ['Meal serving at high dietary protein', 'Meal serving at low dietary protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Institute of Sports Medicine Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Grith Højfeldt, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}, {'name': 'Lars Holm, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc. Human Biology - PhD student', 'investigatorFullName': 'Grith Højfeldt', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}