Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 6:14 PM
Study NCT ID:
NCT04876495
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'single-blind, randomised, triple crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-05-02', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)', 'timeFrame': 'Glucose measured 10 minutes prior to protein shake consumption', 'description': 'Marker: glucose (mmol/L)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)', 'timeFrame': 'Glucose measured 30 minutes post protein shake consumption', 'description': 'Marker: glucose (mmol/L)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)', 'timeFrame': 'Glucose measured 60 minutes post protein shake consumption', 'description': 'Marker: glucose (mmol/L)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)', 'timeFrame': 'Glucose measured 120 minutes post protein shake consumption', 'description': 'Marker: glucose (mmol/L)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)', 'timeFrame': 'Glucose measured 180 minutes post protein shake consumption', 'description': 'Marker: glucose (mmol/L)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)', 'timeFrame': 'Insulin measured 10 minutes prior to protein shake consumption', 'description': 'Marker: insulin (ng/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)', 'timeFrame': 'Insulin measured 30 minutes post protein shake consumption', 'description': 'Marker: insulin (ng/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)', 'timeFrame': 'Insulin measured 60 minutes post protein shake consumption', 'description': 'Marker: insulin (ng/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)', 'timeFrame': 'Insulin measured 120 minutes post protein shake consumption', 'description': 'Marker: insulin (ng/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)', 'timeFrame': 'Insulin measured 180 minutes post protein shake consumption', 'description': 'Marker: insulin (ng/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10)', 'timeFrame': 'Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption', 'description': 'Markers: glucagon-like peptide 1 (pM)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30)', 'timeFrame': 'Glucagon-like peptide 1 measured 30 minutes post protein shake consumption', 'description': 'Markers: glucagon-like peptide 1 (pM)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60)', 'timeFrame': 'Glucagon-like peptide 1 measured 60 minutes post protein shake consumption', 'description': 'Markers: glucagon-like peptide 1 (pM)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120)', 'timeFrame': 'Glucagon-like peptide 1 measured 120 minutes post protein shake consumption', 'description': 'Markers: glucagon-like peptide 1 (pM)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180)', 'timeFrame': 'Glucagon-like peptide 1 measured 180 minutes post protein shake consumption', 'description': 'Markers: glucagon-like peptide 1 (pM)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10)', 'timeFrame': 'Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption', 'description': 'Markers: peptide tyrosine tyrosine (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30)', 'timeFrame': 'Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption', 'description': 'Markers: peptide tyrosine tyrosine (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60)', 'timeFrame': 'Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption', 'description': 'Markers: peptide tyrosine tyrosine (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120)', 'timeFrame': 'Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption', 'description': 'Markers: peptide tyrosine tyrosine (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180)', 'timeFrame': 'Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption', 'description': 'Markers: peptide tyrosine tyrosine (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)', 'timeFrame': 'Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption', 'description': 'Markers: ghrelin (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)', 'timeFrame': 'Ghrelin (pg/mL) measured 30 minutes post protein shake consumption', 'description': 'Markers: ghrelin (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)', 'timeFrame': 'Ghrelin (pg/mL) measured 60 minutes post protein shake consumption', 'description': 'Markers: ghrelin (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)', 'timeFrame': 'Ghrelin (pg/mL) measured 120 minutes post protein shake consumption', 'description': 'Markers: ghrelin (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)', 'timeFrame': 'Ghrelin (pg/mL) measured 180 minutes post protein shake consumption', 'description': 'Markers: ghrelin (pg/mL)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected immediately prior to protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T30)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T60)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected 90 minutes after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T120)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected 150 minutes after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}, {'measure': 'To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T180)', 'timeFrame': 'Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)'}], 'secondaryOutcomes': [{'measure': 'To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO®', 'timeFrame': 'VAS for Palatability collected immediately after protein shake consumption', 'description': 'Subjective analysis including: Visual Analogue Scale for Palatability (VAS-P). Scores range from 0 to 100 (the higher the score the lower the palatability)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutraceutical', 'protein', 'whey', 'potato protein', 'rice protein', 'appetite', 'satiety', 'insulin', 'glucose', 'appetite hormone', 'GLP-1', 'PYY', 'supplement'], 'conditions': ['Appetite and General Nutritional Disorders']}, 'descriptionModule': {'briefSummary': 'INTRODUCTION: Global protein consumption has been increasing for decades due to changes in socio-economic demographics and consumer trends towards higher protein intake, which may be related to their health benefits in performance nutrition and appetite regulation. The additional intake of protein often occurs in the form of supplements. One of the main ingredients used in sports and weight loss supplements are animal-derived proteins such as whey, which are of high quality, containing all the essential amino acids required in human nutrition with a high absorption rate. However, whey protein has a high environmental footprint, and it may contribute to insulin resistance in susceptible groups (e.g. obese, T2DM, insulin resistant, or those with sarcopenic obesity).\n\nRice and potato protein isolates are high-quality plant proteins containing all essential amino acids comparably to whey protein. These plant-derived proteins may provide a more sustainable and accessible alternative to animal-derived proteins for appetite regulation and weight management.', 'detailedDescription': "Intervention study with three treatment groups in a randomised, single-blind, triple crossover design.\n\nStudy population: Healthy male participants will receive three different isocaloric and -volumetric protein shakes prepared using whey, rice and potato protein powders on different trial days with at least a one-week washout period apart.\n\nBiological samples (blood and saliva samples) are collected at various time points during the visit. Blood samples are collected at baseline 10 min prior (T-10), then at 30 min (T30), 60 min (T60), 120 min (T120) and at 180 min (T180) after protein shake consumption. Saliva samples are collected at baseline (T-10), then at every 30 minutes following protein shake consumption (T30, T60, T90, T120, T150, T180). In addition, pertinent questionnaires Visual Analogue Scale \\[VAS\\] for the assessment of satiety and VAS for the assessment of protein shakes' perception will be collected at T-10, T30, T60, T90, T120, T150, T180 and at T0, respectively"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': "Participants' eligibility is based on self-representation of gender identity", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males (18-65 years of age)\n* Healthy subjects\n\nExclusion Criteria:\n\n* \\<18 years or \\>65 years\n* Consumption of \\>21 units of alcohol/week\n* Dieters\n* Any allergies/health issues related to items being ingested\n* Any serious illnesses or those on medication\n* Any illness affecting taste or appetite\n* Any gastrointestinal disorders\n* Any eating disorders\n* Any depression/mental disorders\n* Smoking'}, 'identificationModule': {'nctId': 'NCT04876495', 'acronym': 'PROTEIN', 'briefTitle': 'The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Westminster'}, 'officialTitle': 'Comparative Effects of Dairy and Plant-based Protein Intake on Acute Glucose Homeostasis and Appetite Regulation in Healthy Men', 'orgStudyIdInfo': {'id': 'VRE1516-1375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whey protein', 'description': 'Whey protein isolate (45.5g total protein content)', 'interventionNames': ['Dietary Supplement: Whey protein isolate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Potato protein', 'description': 'Potato protein isolate (45.3g total protein content)', 'interventionNames': ['Dietary Supplement: Potato protein isolate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rice protein', 'description': 'Rice protein isolate (45.5g total protein content)', 'interventionNames': ['Dietary Supplement: Rice protein isolate']}], 'interventions': [{'name': 'Whey protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Instantized BiPRO® 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake.\n\nOther ingredients in the whey protein shake:\n\n* Tropicana Trop50 Orange Juice 207mL\n* Water 43 mL\n* Sucralose 0.5g\n\nThe total energy 233.47Kcal.\n\nParticipants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study.', 'armGroupLabels': ['Whey protein']}, {'name': 'Potato protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Solanic®100 48g (equiv. 45.3g of total protein) presented to participants in a form of a shake.\n\nOther ingredients in the potato protein shake:\n\n* Tropicana Trop50 Orange Juice 250mL\n* Sucralose 0.5g\n\nThe total energy 233.46Kcal\n\nParticipants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study.', 'armGroupLabels': ['Potato protein']}, {'name': 'Rice protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oryzatein® Silk 90 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake.\n\nOther ingredients in the rice protein shake:\n\n* Tropicana Trop50 Orange Juice 183mL\n* Water 67mL\n* Sucralose 0.5g\n\nThe total energy 233.43Kcal\n\nParticipants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study.', 'armGroupLabels': ['Rice protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W1W 6UW', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'University of Westminster', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Mohammed Gulrez Zariwala, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Westminster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Westminster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coventry University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Translational Physiology', 'investigatorFullName': 'Mohammed Gulrez Zariwala', 'investigatorAffiliation': 'University of Westminster'}}}}