The Role of Whey and Lupin in Glycemic Control (Nutritional Pre-Study)
NPS
Short-term Effects of Lupin Versus Whey Protein on Glucose and Insulin Responses to a Standardized Meal in a Randomized Controlled Trial
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
The study compared the acute effects of the supplementation of a standardized meal with either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 10, 2015
CompletedOctober 13, 2016
October 1, 2016
1 month
March 24, 2015
October 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Glucose Metabolism by Blood Glucose and Serum Insulin (composite)
up to 180 minutes after the test meal was finished
Study Arms (3)
Lupin Protein
OTHERSubjects received a test meal rich in carbohydrates and supplemented with lupin protein.
Whey Protein
OTHERSubjects received a test meal rich in carbohydrates and supplemented with whey protein.
Reference
OTHERSubjects received a test meal rich in carbohydrates not supplemented with any protein.
Interventions
Subjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein.
Subjects received a standardized test meal rich in carbohydrates and supplemented with whey protein.
Subjects received a standardized test meal rich in carbohydrates and not supplemented with any protein.
Eligibility Criteria
You may qualify if:
- Female and male volunteers
- Age: between 20 and 45 years
- Body mass index (BMI): 20-28 kg/m²
- Fasting blood glucose within normal ranges (70-99 mg/dl; 29-42 mmol/mol Hb)
- Glycated hemoglobin HbA1c within normal ranges (4-6%)
- Agreement and signed informed consent before the study
You may not qualify if:
- Diabetes mellitus
- Increased bleeding tendency (hemophilia, regular use of anticoagulants)
- Allergy to nuts, legume or milk protein
- Drug, medication or alcohol abuse (frequent consumption of more than 20-30g alcohol/day)
- Intake of medication during the study
- Smoker
- Competitive athletes
- Extreme eating habits (vegan, special diets)
- Any other condition classed as unsuitable by the executive medical director
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jörn Rittweger, Prof. Dr.
DLR German Aerospace Center
- PRINCIPAL INVESTIGATOR
Ann-Charlotte Ewald
DLR German Aerospace Center
- PRINCIPAL INVESTIGATOR
Kathrin Schopen, M.Sc.
DLR German Aerospace Center
- PRINCIPAL INVESTIGATOR
Petra Frings-Meuthen, Dr.
DLR German Aerospace Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 10, 2015
Study Start
June 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 13, 2016
Record last verified: 2016-10