NCT01682174

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

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

September 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

Same day

First QC Date

September 6, 2012

Last Update Submit

May 7, 2013

Conditions

Glycaemic IndexGlycaemic Response

Outcome Measures

Primary Outcomes (1)

  • Glycaemic response (incremental area under the curve) of experimental test food using capillary blood

    120 minutes

Study Arms (2)

Control Test Drink

PLACEBO COMPARATOR

control drink

Other: Control DrinkOther: Experimental Drink

Experimental Test Drink

EXPERIMENTAL

Experimental Drink

Other: Control DrinkOther: Experimental Drink

Interventions

Control DrinkOTHER
Control Test DrinkExperimental Test Drink
Experimental DrinkOTHER
Control Test DrinkExperimental 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% Male)
  • Aged 18 - 55 years
  • Non Smokers
  • Have a body mass index between 18.5 to 29.99 kg/m2
  • Healthy, non-diabetic, no gastric bypass surgery
  • Not allergic to dairy, or soy
  • Have 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

Study Sites (1)

Reading Scientific Services Limited (RSSL)

Reading, Berkshire, United Kingdom

Location

Study Officials

  • Rungano Munyuki

    RSSL

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2012

First Posted

September 10, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 9, 2013

Record last verified: 2013-05

Locations

GB(1)