The Effect of Lactisole on the Responses to Glucose Solution

Not Applicable

• Conditions: Blood Glucose; Appetite; Therapeutic Uses; Hormones
• Interventions: Dietary Supplement: Lactisole

• Registration Number: NCT01121783
• Lead Sponsor: Northern Care Alliance NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Study First Posted: 2010-05-12
• Last Update Posted: 2010-05-12
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactisole-Glucose	Lactisole	-
Lactisole-water	Lactisole	-
Water-Glcuose	Lactisole	-
Water-Water	Lactisole	-

Primary Outcome Measures

Name	Time	Method
Blood glucose	Blood samples will be collected at baseline and 5, 15 and 30 minute intervals until 150 minutes after the glucose infusion

Secondary Outcome Measures

Name	Time	Method
Subjective appetite ratings	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
Gastric emptying rate	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.
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
Gut hormones	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.

Trial Locations

Locations (1)

Salford Royal NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom