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

NCT ID: NCT02413671

Last Updated: 2016-10-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Whole Body Glucose and Insulin Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lupin Protein

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

Group Type OTHER

Lupin Protein

Intervention Type DIETARY_SUPPLEMENT

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

Whey Protein

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

Group Type OTHER

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

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

Reference

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

Group Type OTHER

Reference

Intervention Type OTHER

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

Interventions

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Lupin Protein

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

Intervention Type DIETARY_SUPPLEMENT

Whey Protein

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

Intervention Type DIETARY_SUPPLEMENT

Reference

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DLR German Aerospace Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jörn Rittweger, Prof. Dr.

Role: STUDY_DIRECTOR

DLR German Aerospace Center

Ann-Charlotte Ewald

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

Kathrin Schopen, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

Petra Frings-Meuthen, Dr.

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

Other Identifiers

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NPS

Identifier Type: -

Identifier Source: org_study_id

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