Clinical trial NCT01121783: The Effect of Lactisole on the Responses to Glucose Solution
Official title: Study of the Effect of Lactisole on the Responses to Intragastric Glucose Solution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Glucose
Appetite
Therapeutic Uses
Hormones
Lead sponsor: Northern Care Alliance NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2010-05-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Obesity is epidemically prevalent and a major risk factor for chronic diseases making it fundamental to understand the pathways controlling food intake. During the course of a meal and afterwards the gut and brain communicate to control how full the eater feels and thus control the amount of food eaten. The information relayed from the gut to the brain regarding ingested nutrients is of increasing importance and understanding the mechanisms by which nutrient molecules are initially detected in the gut and how they signal to the brain to influence food intake is critical to the development of novel food products that could induce fullness and reduce food consumption. Increasing our understanding of how nutrients are sensed in the gut and how this may influence subsequent food intake provides promising targets for obesity prevention and treatment. Recent discoveries have shown that sweet taste receptors similar to those located in the tongue are present in the gut. It is suggested that theses receptors are involved in the way nutrients are sensed and may play an important role in appetite control and food intake.

Eligibility criteria: Inclusion Criteria:

* Aged between 18-45 years
* BMI between 18-25kg/m2
* General good health

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood glucose
timeFrame: Blood samples will be collected at baseline and 5, 15 and 30 minute intervals until 150 minutes after the glucose infusion
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 30 minute intervals
measure: Gastric emptying rate
timeFrame: Breath samples are collected at 5, 15 and 30 minute intervals up to a total of 10 times until 150 minutes
measure: Energy intake
measure: Gut hormones
timeFrame: Blood samples will be collected at baseline, 5, 15 and 30 minute intervals until 150 minutes after glucose infusion.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: David Thompson, FRCP, fMedSci,
role: PRINCIPAL_INVESTIGATOR
References: