Blood Glucose and Insulin Responses to Snack Food Products

NCT01341769 | Withdrawn

• 1 other identifier: P10-08857 version 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.

Conditions

Study Focus 1:Glycaemic Index; Study Focus 2:Glycaemic Response; Study Focus 3:Insulinemic Response

Outcome Measures

Primary Outcomes (1)

• Glycaemic index of experimental test foods compared to that of control test food using venous plasma.

  0-120 minutes

Secondary Outcomes (4)

• Glycaemic index of experimental test foods compared to that of control test food using capillary blood

  0-120 minutes

• Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood

  0-180 minutes

• Measure insulin in venous plasma

  0-180 minutes

• Measure C-peptide in venous plasma

  0-180 minutes

Study Arms (4)

Control Test Food

PLACEBO COMPARATOR

Snack base

Other: Dietary Intervention

Experimental Test Food 1

EXPERIMENTAL

Snack Base containing ingredient 1

Other: Dietary Intervention

Experimental Test Food 2

EXPERIMENTAL

Snack base containing ingredient 2

Other: Dietary Intervention

Experimental Test Food 3

EXPERIMENTAL

Snack base containing ingredients 1 and 2

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

Control Test Food

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female (not less than 40% males or females
• Non-smoker
• Aged 18 to 55 years
• Have a body mass index between 18.5 to 29.99 kg/m2
• Fasting blood glucose (finger-stick) \>3.3 and \<5.6 mmol/L (Visit 2)
• Two-hour OGTT glucose (finger-stick) \<7.8 mmol/L (Visit 2)
• Willing and able to provide written informed consent

You may not qualify if:

• Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
• Any significant concurrent illness
• History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
• Have assessed an investigational product for GI in the last 72 hours.
• Concurrent participation in any other safety study
• History of diabetes, hepatitis, AIDS, anaemia or a heart condition
• The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.
• Had any type of gastrointestinal surgery, including gastric bypass
• Having consumed anything apart from plain water in the 12 hours prior to each test
• Have been medically diagnosed as having high blood pressure or heart disease

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• Reading Scientific Services Ltd.: collaborator

Study Sites (1)

Reading Scientific Services Limited

Reading, Berkshire, RG6 6BZ, United Kingdom

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Valerie Hart, SCS, Dip, MICR

  Reading Scientific Services Limited

  STUDY DIRECTOR

• Dr. Suzana Louth

  Reading Scientific Services Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: April 26, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

GB (1)