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

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.

Study Overview

• Status: Completed
• Conditions: Whole Body Glucose and Insulin Metabolism
• Intervention / Treatment: Dietary supplement: Lupin Protein; Dietary supplement: Whey Protein; Other: Reference

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lupin Protein; Subjects received a test meal rich in carbohydrates and supplemented with lupin protein.	Dietary supplement: Lupin Protein; Subjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein.
Other: Whey Protein; Subjects received a test meal rich in carbohydrates and supplemented with whey protein.	Dietary supplement: Whey Protein; Subjects received a standardized test meal rich in carbohydrates and supplemented with whey protein.
Other: Reference; Subjects received a test meal rich in carbohydrates not supplemented with any protein.	Other: Reference; Subjects received a standardized test meal rich in carbohydrates and not supplemented with any protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Glucose Metabolism by Blood Glucose and Serum Insulin (composite)	up to 180 minutes after the test meal was finished

Collaborators and Investigators

• Sponsor: DLR German Aerospace Center
• Investigators: Principal Investigator: Ann-Charlotte Ewald, DLR German Aerospace Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: NPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No