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

Not Applicable

Completed

• Conditions: Whole Body Glucose and Insulin Metabolism
• Interventions: Dietary Supplement: Lupin Protein; Other: Reference; Dietary Supplement: Whey Protein

• Registration Number: NCT02413671
• Lead Sponsor: DLR German Aerospace Center

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.

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 Timeline

• Study Start: 2013-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lupin Protein	Lupin Protein	Subjects received a test meal rich in carbohydrates and supplemented with lupin protein.
Reference	Reference	Subjects received a test meal rich in carbohydrates not supplemented with any protein.
Whey Protein	Whey Protein	Subjects received a test meal rich in carbohydrates and supplemented with whey protein.

Primary Outcome Measures

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