The Effect of Lactisole on the Responses to Glucose Solution

NCT ID: NCT01121783

Last Updated: 2010-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Blood Glucose Appetite Therapeutic Uses Hormones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Lactisole-Glucose

Group Type ACTIVE_COMPARATOR

Lactisole

Intervention Type OTHER

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.

Lactisole-water

Group Type ACTIVE_COMPARATOR

Lactisole

Intervention Type DIETARY_SUPPLEMENT

A pre-infusion of lactisole solution (0.25mg/ml)is administered as a bolus (1ml/kg body weight) via intragastric tube. After 15 minutes tap water will be administered as a bolus via the intragastric tube.

Water-Glcuose

Group Type PLACEBO_COMPARATOR

Lactisole

Intervention Type DIETARY_SUPPLEMENT

A pre-infusion of tap water(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.

Water-Water

Group Type PLACEBO_COMPARATOR

Lactisole

Intervention Type DIETARY_SUPPLEMENT

A pre-infusion of tap water is administered as a bolus (1ml/kg bodyweight)via intragastric tube. After 15 minutes tap water is administered as a bolus via intragastric tube.

Interventions

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Lactisole

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.

Intervention Type OTHER

Lactisole

A pre-infusion of lactisole solution (0.25mg/ml)is administered as a bolus (1ml/kg body weight) via intragastric tube. After 15 minutes tap water will be administered as a bolus via the intragastric tube.

Intervention Type DIETARY_SUPPLEMENT

Lactisole

A pre-infusion of tap water(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.

Intervention Type DIETARY_SUPPLEMENT

Lactisole

A pre-infusion of tap water is administered as a bolus (1ml/kg bodyweight)via intragastric tube. After 15 minutes tap water is administered as a bolus via intragastric tube.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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University of Manchester

Principal Investigators

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David Thompson, FRCP, fMedSci,

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Salford Royal NHS Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Nerys M Astbury, Bsc. MMedSci, PhD

Role: primary

0161 206 1447

Charlotte E Bryant, Bsc, MMedSci

Role: backup

0161 2061447

Other Identifiers

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Lactisole

Identifier Type: -

Identifier Source: org_study_id

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