NCT01536847

Brief Summary

The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

February 16, 2012

Last Update Submit

September 7, 2012

Conditions

Glycaemic IndexGlycaemic Response

Outcome Measures

Primary Outcomes (1)

  • Glycaemic index of experimental test food using capillary blood

    0-120 minutes

Study Arms (3)

Control Test Drink

PLACEBO COMPARATOR

Control drink

Other: Dietary Intervention

Experimental Test Drink 1

EXPERIMENTAL

Control drink containing ingredient 1

Other: Dietary Intervention

Experimental Test Drink 2

EXPERIMENTAL

Control drink containing ingredient 2

Other: Dietary Intervention

Interventions

Dietary InterventionOTHER

300 ml of liquid food product

Control Test Drink

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • Healthy, non-diabetic, no gastric bypass surgery
  • Having a fasting plasma glucose (finger stick) \<100 mg/dl (\<5.5 mmol/L)
  • Willing and able to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Suzana Louth, Dr

    RSSL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 10, 2012

Record last verified: 2012-09