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CompletedNCT02413671NPSUpdated Oct 13, 2016

The Role of Whey and Lupin in Glycemic Control (Nutritional Pre-Study)

An interventional study of Lupin Protein and Whey Protein in Whole Body Glucose and Insulin Metabolism, sponsored by DLR German Aerospace Center. Completed. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-13.

Sponsored by DLR German Aerospace Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

The nutritional pre-study had the following key objectives:

Primary objective:

- Lupin protein lowers the postprandial blood glucose level equivalent to or to a greater extent than whey protein.

Secondary objective:

- Lupin protein has an equivalent or a stronger insulinotropic effect than whey protein.

02

Conditions studied

  • Whole Body Glucose and Insulin Metabolism
03

In context

Lead sponsor

DLR German Aerospace Center is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
12 participants (actual)

Study arms

  • Other
    Lupin Protein

    Subjects received a test meal rich in carbohydrates and supplemented with lupin protein.

    Dietary Supplement: Lupin Protein

  • Other
    Whey Protein

    Subjects received a test meal rich in carbohydrates and supplemented with whey protein.

    Dietary Supplement: Whey Protein

  • Other
    Reference

    Subjects received a test meal rich in carbohydrates not supplemented with any protein.

    Other: Reference

Interventions

  • Dietary supplementLupin Protein

    Subjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein.

  • Dietary supplementWhey Protein

    Subjects received a standardized test meal rich in carbohydrates and supplemented with whey protein.

  • OtherReference

    Subjects received a standardized test meal rich in carbohydrates and not supplemented with any protein.

06

What researchers measure

Primary outcomes

  1. Blood Glucose Metabolism by Blood Glucose and Serum Insulin (composite)

    Time frame: up to 180 minutes after the test meal was finished

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2015
First posted
Apr 10, 2015
Start
Jun 2013
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Last update
Oct 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02413671
Lead sponsor
DLR German Aerospace Center
Responsible party
Sponsor
First posted
Apr 10, 2015
Start date
Jun 2013
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Oct 13, 2016

Study contacts

Jörn Rittweger, Prof. Dr.
study director · DLR German Aerospace Center
Ann-Charlotte Ewald
principal investigator · DLR German Aerospace Center
Kathrin Schopen, M.Sc.
principal investigator · DLR German Aerospace Center
Petra Frings-Meuthen, Dr.
principal investigator · DLR German Aerospace Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Whey Proteins

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DLR German Aerospace Center

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