Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines

NCT04610203 | Completed

• 2 other identifiers: CPS 18-439pfact 9806
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.

Conditions

Healthy

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

Secondary Outcomes (8)

• Change in GLP-1 from baseline for 3 hours

  3 hours

• Change in GIP from baseline for 3 hours

  3 hours

• Area under the plasma GLP-1 concentration versus time curve

  3 hours

• Area under the plasma GIP concentration versus time curve

  3 hours

• Peak plasma GLP-1 concentration (Cmax)

  0-3 hours

Study Arms (3)

Glucose

PLACEBO COMPARATOR

Glucose - 50 g

Dietary Supplement: 50 g Glucose

Nutralys S85 Plus 25 g

EXPERIMENTAL

Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose

Dietary Supplement: 25 g Nutralys Pea Protein

Nutralys S85 Plus 50 g

EXPERIMENTAL

Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose

Dietary Supplement: 50 g Nutralys S85 Plus.

Interventions

25 g Nutralys Pea Protein DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus

Nutralys S85 Plus 25 g

50 g Nutralys S85 Plus. DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .

Nutralys S85 Plus 50 g

50 g Glucose DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose

Glucose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Oxford Brookes University: lead
• Roquette Freres: collaborator

Study Sites (1)

Oxford Brookes Centre for Nutrition and Health

Oxford, OX3 0BP, United Kingdom

Location

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: 20359723 BACKGROUND

Related Links

• 23\. Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Sangeetha Thondre, PhD

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

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

Model Details: randomised, repeat measure, crossover design trial

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 30, 2020
• Study Start: December 3, 2018
• Primary Completion: July 5, 2019
• Study Completion: September 30, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)