The Effect of Lactisole on the Responses to Glucose Solution
Study of the Effect of Lactisole on the Responses to Intragastric Glucose Solution
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of the study is to determine whether the sweet taste receptors in the gut are involved in sensing sweet substances and controlling appetite and the amount we eat. Lactisole is a substance commonly used in food products to reduce the perceived sweetness of certain sugars and sweeteners. The aim of this study is to investigate whether the responses to a glucose solution, intragastrically administered to healthy male and female volunteers, is affected by the presence of lactisole in the gut. Understanding the mechanisms by which nutrients are initially detected in the gut and how they influence food intake is critical to the development of novel food products that could reduce food consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 12, 2010
March 1, 2010
1 year
May 10, 2010
May 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Blood glucose
Blood samples will be collected at baseline and 5, 15 and 30 minute intervals until 150 minutes after the glucose infusion
Secondary Outcomes (4)
Subjective appetite ratings
30 minute intervals
Gastric emptying rate
Breath samples are collected at 5, 15 and 30 minute intervals up to a total of 10 times until 150 minutes
Energy intake
Gut hormones
Blood samples will be collected at baseline, 5, 15 and 30 minute intervals until 150 minutes after glucose infusion.
Study Arms (4)
Lactisole-Glucose
ACTIVE COMPARATORLactisole-water
ACTIVE COMPARATORWater-Glcuose
PLACEBO COMPARATORWater-Water
PLACEBO COMPARATORInterventions
A pre-infusion of lactisole solution (0.25mg/ml) is administered as a bolus (1ml/kg bodyweight)via intragastric tube. After 15 minutes a 1M glucose solution is administered as a bolus via intragastric tube.
Eligibility Criteria
You may qualify if:
- Aged between 18-45 years
- BMI between 18-25kg/m2
- General good health
You may not qualify if:
- Underweight or Overweight (Body Mass Index \<19 or \>25 kg.m-2)
- Females who are pregnant or breastfeeding
- Currently taking medication (except females taking oral contraceptive)
- Smokers
- Currently dieting or have experienced a weight change +/- 3kg in past 6 months
- Metabolic disorders (eg. Type 2 diabetes)
- History of gastrointestinal disorders
- Participation in other research in past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Salford Royal NHS Foundation Trust
Manchester, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
David Thompson, FRCP, fMedSci,
University of Manchester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 12, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 12, 2010
Record last verified: 2010-03