Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein
2 other identifiers
interventional
30
1 country
1
Brief Summary
A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2021
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2022
CompletedSeptember 7, 2022
September 1, 2022
10 months
April 29, 2021
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
Change in blood glucose response from baseline for 3 hours
Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours
3 hours
Change in plasma insulin response from baseline for 3 hours
Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours
3 hours
Area under the blood glucose concentration versus time curve
Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule
3 hours
Area under the plasma insulin concentration versus time curve
Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule
3 hours
Peak blood glucose concentration (Cmax)
Peak blood glucose concentration (Cmax) after consumption of the test food
0-3 hours
Peak plasma insulin concentration (Cmax)
Peak plasma insulin concentration (Cmax) after consumption of the test food
0-3 hours
Time of blood glucose peak (Tmax)
Time of blood glucose peak after consumption of the test food
0-3 hours
Time of plasma insulin peak (Tmax)
Time of plasma insulin peak after consumption of the test food
0-3 hours
Study Arms (5)
Glucose
PLACEBO COMPARATORGlucose 50 g available carbohydrate
10 g NUTRALYS®S85 Plus pea protein
EXPERIMENTAL50 g available carbohydrate Glucose + 10 g NUTRALYS®S85 Plus pea protein
20 g NUTRALYS®S85 Plus pea protein
EXPERIMENTAL50 g available carbohydrate Glucose + 20 g NUTRALYS®S85 Plus pea protein
10 g Whey protein concentrate
EXPERIMENTAL50 g available carbohydrate Glucose + 10 g Whey protein concentrate
20 g Whey protein concentrate
EXPERIMENTAL50 g available carbohydrate Glucose + 20 g Whey protein concentrate
Interventions
To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g NUTRALYS®S85 Plus pea protein.
To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.
To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.
To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.
To determine the glycaemic response and insulinaemic response to 50g Glucose
Eligibility Criteria
You may qualify if:
- Aged 18 to 60 years
- Body mass index (BMI) less than 30kg/m2
You may not qualify if:
- Pregnant or lactating
- Fasting blood glucose value \> 6.1 mmol/l
- Any known food allergy or intolerance
- Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
- Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions
- Major medical or surgical event requiring hospitalization within the preceding 3 months
- Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution)
- Unable to comply with experimental procedures or did not follow GR testing safety guidelines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxford Brookes Universitylead
- Roquette Frerescollaborator
Study Sites (1)
Oxford Brookes Centre for Nutrition and Health
Oxford, OX3 0BP, United Kingdom
Related Publications (1)
Siahanidou T, Margeli A, Kappis A, Papassotiriou I, Mandyla H. Circulating visfatin levels in healthy preterm infants are independently associated with high-density lipoprotein cholesterol levels and dietary long-chain polyunsaturated fatty acids. Metabolism. 2011 Mar;60(3):389-93. doi: 10.1016/j.metabol.2010.03.002. Epub 2010 Mar 31.
PMID: 20359723BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sangeetha Thondre, PhD
Oxford Brookes University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 4, 2021
Study Start
September 15, 2021
Primary Completion
July 13, 2022
Study Completion
August 29, 2022
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share