Blood GlucoseNCT01121783
The Effect of Lactisole on the Responses to Glucose Solution
A study testing Lactisole in people with Blood Glucose and Appetite, run by Northern Care Alliance NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Appetite, Therapeutic Uses
- What is being tested?
- Lactisole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-45 years
- BMI between 18-25kg/m2
- General good health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Salford Royal NHS Foundation Trust
Manchester
Nerys M Astbury, Bsc. MMedSci, PhD, 0161 206 1447, nerys.astbury@manchester.ac.uk
Charlotte E Bryant, Bsc, MMedSci, 0161 2061447, charlotte.bryant@postgrad.manchester.ac.uk
About this study
Official title: Study of the Effect of Lactisole on the Responses to Intragastric Glucose Solution
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.
Read the 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.
- Conditions
- Blood Glucose, Appetite, Therapeutic Uses, Hormones
- Being tested
- Lactisole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactisoleOther
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.
LactisoleDietary 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.
LactisoleDietary 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.
LactisoleDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Lactisole-Glucose | Active comparator | Not described Receives: Other: Lactisole |
| Lactisole-water | Active comparator | Not described Receives: Dietary Supplement: Lactisole |
| Water-Glcuose | Placebo comparator | Not described Receives: Dietary Supplement: Lactisole |
| Water-Water | Placebo comparator | Not described Receives: Dietary Supplement: Lactisole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Measured: 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
Participants will be asked to complete visual analogue scale questionnaire (VAS) up to a total of 6 times for the duration of each study
Measured: 30 minute intervals
Gastric emptying rate
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.
Measured: Breath samples are collected at 5, 15 and 30 minute intervals up to a total of 10 times until 150 minutes
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 processed to examine hormone levels of GLP-1, PYY, and insulin.
Measured: Blood samples will be collected at baseline, 5, 15 and 30 minute intervals until 150 minutes after glucose infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Care Alliance NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Investigators
- David Thompson, FRCP, fMedSci,, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121783
- Sponsor's protocol ID
- Lactisole
- Status last verified
- Mar 2010
- First submitted
- 10 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Lactisole on the Responses to Intragastric Glucose Solution
- ClinicalTrials.gov ID
- NCT01121783
- Acronym / sponsor ID
- Lactisole
- Conditions
- Blood Glucose, Appetite, Therapeutic Uses, Hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Northern Care Alliance NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- May 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactisole-Glucose | Active comparator | Other: Lactisole |
| Lactisole-water | Active comparator | Dietary Supplement: Lactisole |
| Water-Glcuose | Placebo comparator | Dietary Supplement: Lactisole |
| Water-Water | Placebo comparator | Dietary Supplement: Lactisole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18-45 years
- BMI between 18-25kg/m2
- General good health
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactisoleA 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. | Other | Lactisole-Glucose |
| LactisoleA 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. | Dietary supplement | Lactisole-water |
| LactisoleA 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. | Dietary supplement | Water-Glcuose |
| LactisoleA 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. | Dietary supplement | Water-Water |
Primary outcome
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
4 secondary outcomes
Subjective appetite ratings
Time frame: 30 minute intervals
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
Energy intake
Gut hormones
Time frame: Blood samples will be collected at baseline, 5, 15 and 30 minute intervals until 150 minutes after glucose infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salford Royal NHS Foundation Trust
Manchester, United Kingdom
David Thompson, FRCP, fMedSci, principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactisole in people with Blood Glucose and Appetite, run by Northern Care Alliance NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.