Blood Glucose and Insulin Responses to Snack Food Products

Mondelez International

Status: Withdrawn

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

Treatments: Other: Dietary Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT01341769

P10-08857 version 01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Control Test Food

Placebo Comparator group

Description:

Snack base

Treatment:

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Experimental Test Food 1

Experimental group

Description:

Snack Base containing ingredient 1

Treatment:

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Experimental Test Food 2

Experimental group

Description:

Snack base containing ingredient 2

Treatment:

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Experimental Test Food 3

Experimental group

Description:

Snack base containing ingredients 1 and 2

Treatment:

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention

Other: Dietary Intervention