Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2011-02-28
2011-11-30
Brief Summary
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Detailed Description
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In each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: After a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. After a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Lupin Protein
Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)
Protein drink - low dosage
The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Protein drink - high dosage
The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Reference protein
Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)
Protein drink - low dosage
The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Protein drink - high dosage
The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Wash out
Wash out (four weeks without any intervention between interventional periods)
No interventions assigned to this group
Interventions
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Protein drink - low dosage
The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Protein drink - high dosage
The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Eligibility Criteria
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Inclusion Criteria
* Age: 18-80 years old
Exclusion Criteria
* Allergy against legumes or milk protein
* Intolerance against milk
* Pregnancy, lactation
* Chronic bowel disease
18 Years
80 Years
ALL
Yes
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
University of Jena
OTHER
Responsible Party
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Gerhard Jahreis
Prof. Dr. habil.
Principal Investigators
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Gerhard Jahreis, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
Locations
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Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany
Countries
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References
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Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.
Other Identifiers
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LSEP H48-11
Identifier Type: -
Identifier Source: org_study_id