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The Effect of Lactisole on the Responses to Glucose Solution

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ClinicalTrials.gov Identifier: NCT01121783
Recruitment Status : Unknown
Verified March 2010 by Salford Royal NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Blood Glucose Appetite Therapeutic Uses Hormones Other: Lactisole Dietary Supplement: Lactisole

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Study of the Effect of Lactisole on the Responses to Intragastric Glucose Solution
Study Start Date : May 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Lactisole-Glucose Other: 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.
Active Comparator: Lactisole-water Dietary Supplement: 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.
Placebo Comparator: Water-Glcuose 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.
Placebo Comparator: Water-Water 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.


Outcome Measures

Primary Outcome Measures :
  1. Blood glucose [ Time Frame: Blood samples will be collected at baseline and 5, 15 and 30 minute intervals until 150 minutes after the glucose infusion ]

Secondary Outcome Measures :
  1. Subjective appetite ratings [ Time Frame: 30 minute intervals ]
    Participants will be asked to complete visual analogue scale questionnaire (VAS) up to a total of 6 times for the duration of each study

  2. Gastric emptying rate [ Time Frame: Breath samples are collected at 5, 15 and 30 minute intervals up to a total of 10 times until 150 minutes ]
    In order to assess gastric emptying, a stable isotope of carbon, in the form of 13Csodium acetate will be added to the test meal. This is absorbed only once it has passed through the stomach into the duodenum. It is then metabolised and exhaled in the breath as 13Clabelled carbon dioxide (CO2) where it can be measured.

  3. Energy intake
    Energy intake will be assessed by an ad libitum test meal provided at the end of each study and food diaries completed for the remainder of the day

  4. Gut hormones [ Time Frame: Blood samples will be collected at baseline, 5, 15 and 30 minute intervals until 150 minutes after glucose infusion. ]
    Blood samples will be processed to examine hormone levels of GLP-1, PYY, and insulin.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121783


Locations
United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Nerys M Astbury, Bsc. MMedSci, PhD    0161 206 1447    nerys.astbury@manchester.ac.uk   
Contact: Charlotte E Bryant, Bsc, MMedSci    0161 2061447    charlotte.bryant@postgrad.manchester.ac.uk   
Principal Investigator: David Thompson, FRCP, fMedSci         
Sponsors and Collaborators
Salford Royal NHS Foundation Trust
University of Manchester
Investigators
Principal Investigator: David Thompson, FRCP, fMedSci, University of Manchester
More Information

Responsible Party: Mohammed Zubair, University of Manchester
ClinicalTrials.gov Identifier: NCT01121783     History of Changes
Other Study ID Numbers: Lactisole
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Pharmaceutical Solutions