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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02477410 |
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Date of registration:
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11/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite
SEPA |
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Scientific title:
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Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02477410 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Arne Astrup, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nutrition, Exercise and Sports, University of Copenhagen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy young men
- Normal weight (BMI 18.5-25 kg/m2)
- 22-40 years
Exclusion Criteria:
- Vegetarians
- Weight change >3kg within 2 months prior to start of the study
- Regular participation in cardio/strength training within 6 months prior to (and
during) the study (>1 per wk)
- Use of alcohol >14 drinks/wk
- Drug abuse
- Smoking
- Regular consumption of protein supplements
- Use of over-the-counter or prescription medication that influences body weight,
appetite or metabolism
- Diabetes Mellitus
- Dyslipidemia
- Diseases, which influence metabolism
- Donation of blood 3 months prior to start of (and during) the study
- Subjects with a hemoglobin value < 8 mol/L (measured at screening)
- Participation in other clinical studies 1 month prior to start of (and during) the
study
- Subjects who are unable to give an informed consent.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hunger
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Protein Synthesis
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Satiety Response
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Intervention(s)
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Dietary Supplement: Hydrolysed porcine protein from blood
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Dietary Supplement: Hydrolysed whey protein
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Dietary Supplement: Hydrolysed porcine protein from muscle
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Primary Outcome(s)
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Change in Muscle protein synthesis (%FSR)
[Time Frame: 13 blood samples are taken over 310 min]
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Change in Muscle protein synthesis (%FSR)
[Time Frame: 3 biopsies are taken at time 0, 150 min and 310 min at each visit]
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Secondary Outcome(s)
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Postprandial response in glycemic control, plasma amino acids and appetite regulating hormones
[Time Frame: Blood samples are taken at 0, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days]
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Appetite - ad libitum energy intake
[Time Frame: Measured once at time 325 min at each of the three test days]
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Visual analogue scales (10 cm)
[Time Frame: Assessed at time 0, 160, 175, 200, 220, 250, 280, 310, 345 min at each of the three test days]
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Secondary ID(s)
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H-15003581
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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