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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04038281
Other study ID # SMEC_2018-19_048
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 15, 2019
Est. completion date November 1, 2019

Study information

Verified date July 2019
Source St Mary's University College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Obesity is an increasing problem for adults in the UK. Diets high in fat and sugar are the major contributors to weight gain. Individual differences in taste perception are a crucial factor in determining the investigator's choice of foods and an individual's sensitivity to the either bitter or fat taste compounds has been linked to a preference for different foods including sweet and high fat foods. Previous research has not comprehensively explored the effect of both fat and bitter taste sensitivity on dietary intake and obesity status. Therefore, the aim of this study is to explore the associations between genetics, fat and bitter taste sensitivity, food preference, dietary intake and obesity measures in the adult UK population.


Description:

Demographic data Participants will complete a questionnaire asking about their demographics provided in Appendix. The answers to these questions will be used to control for potential confounding effects in statistical analysis.

Genetic Analysis Saliva samples (2 ml) will be collected for DNA analyses (Genefix, Isohelix, Kent, UK) and stored in the fridge at 4 °C in M201 lab at St Mary's University. DNA extraction will be carried out through use of a PSP® SalivaGene 17 DNA Kit 1011 following the standard manufacturer protocol. DNA quantification and quality control will be assessed with spectroscopy. Following this, genotyping will be carried out using prepared TaqMan® SNP genotyping assays for genes coding for bitter and fat taste receptors and a StepOnePlus thermocycler. All samples will be analysed in duplicate in accordance with the manufacturer's protocol. All genetic analyses will be carried out at St Mary's University, Twickenham.

Anthropometrics Height (m), weight (kg) and waist circumference (cm) will be recorded by the researcher team. BMI will be calculated using the equation: weight (kg)/ height (m2) ± standard deviation and waist circumference and distribution will be compared to the UK standards.

Fat and bitter taste sensitivity The Oral Fatty Acid Threshold Assessment and Ascending Forced Choice Triangle Procedure will be used to determine each participant's oleic acid (C18:1) detection threshold (fat taste sensitivity). Briefly, each participant will be presented with three cups containing 30 ml vehicles in a random arrangement, two controls and the third containing oleic acid (0.02, 0.06, 1, 1.4, 2, 2.8, 3.8, 5, 6.4, 8, 9.8, 12, 20 mM). Participants will have to identify the oleic acid solution by tasting but not ingesting the solutions. A participant will be required to choose the oleic acid solution correctly three times at the same concentration to define their threshold. If participant is incorrect at any point, further three cups will be presented, one containing the higher concentration. There will be thirteen concentrations in total. The bitter taste compound used to classify participants into bitter taste hypo-, normal- and hypertasters will be PTC. Participants will place a strip on the tongue and use the general Labeled Magnitude Scale (gLMS) to report the intensity of the taste compound.

Food preference Food preference will be measured by asking participants to taste food usually perceived as bitter (dark chocolate and broccoli) as well as food that are defined as sweet (milk chocolate and carrots).To minimise variability, the vegetables will be presented raw. Overall preference will be tested using a nine-point Likert scale. Each participants will rinse their mouth with water between each food and a minimum of one minute will be left between each test. Eating behaviour will be determined by use of the validated Adult Eating Behaviour Questionnaire. Fat preference will be determined by a UK adaption of the validated Fat Preference Questionnaire.

Dietary Intake The validated EPIC Norfolk Food Frequency Questionnaire (FFQ) will be used to measure dietary intake over the previous year.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- healthy adults aged 18-65 years

Exclusion Criteria:

- pregnancy

- breastfeeding

- smoking

- reported any past or present food allergy or lactose intolerance

- under any medication that might affect taste perception

- known illnesses such as cold, ear infection, sinus infection, or flu

- any reported chronic diseases such as (diabetes, CVD, stroke, epilepsy, asthma, cancer)

- any thyroid problems

- individuals that are currently following a diet or weight loss programme

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sensory tests
Fat, bitter taste sensitivity and food preference measurement

Locations

Country Name City State
United Kingdom St Mary's University London

Sponsors (2)

Lead Sponsor Collaborator
St Mary's University College Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Obesity BMI 1 day observation
Secondary Energy intake Energy intake in kcal obtained with FFQ 1 year dietary intake
Secondary Fat intake Fat intake in grams obtained with FFQ 1 year dietary intake
Secondary Sugar intake Sugar intake in grams obtained with FFQ 1 year dietary intake
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