Appetitive BehaviorNCT03585920
The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
A study testing Expanded Corn Snack in people with Appetitive Behavior and Individual Difference, run by University of Reading at 1 site in United Kingdom.
Trial summary
The present study aims to investigate the effect of fat level and fat type of a snack on self-reported satiety and associated biomarkers. The relevant individual differences will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Individual Difference, Food Sensitivity
- What is being tested?
- Expanded Corn Snack
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2018to 25 Oct 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Aged 18-70 years
- Body mass index (BMI): 18-32 kg/m2
- Fasting glucose < 7 mmol/l
- Fasting total cholesterol < 7.5 mmol/L
- Fasting triglycerides < 2.3 mmol/L
- Weight stable in the last three months
Who cannot join
- Diagnosed with diabetes or cardiovascular disease (e.g. stroke or heart attack), gastrointestinal (e.g. Irritable bowel syndrome (IBS), inflammatory conditions, gastroenteritis), endocrine or renal diseases
- Smoker
- Taking prescribed medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
- Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose)
- Drug abuse
- Anaemia (men: haemoglobin<130 g/L and women <115 g/L)
Show all 10Show fewer
- Hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Planning or currently on a weight reducing programme
- Pregnancy, planned pregnancy in the next year or lactating
- Currently taking part or participation in other research studies within the last three months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sensory Science Centre, Department of Food and Nutritional Science, University of Reading
Reading, Berkshire, RG6 6UR
About this study
The present study aims to investigate the effect of fat level and fat type of a snack on self-reported satiety and associated biomarkers. The relevant individual differences will also be investigated.
Read the detailed description
The aims are: (1) To determine whether reducing fat in a snack leads to rebound hunger and higher food intake at the subsequent meal, (2)To determine whether a low fat snack product matched for expected satiety leads to differences in post-ingestive satiety (i.e. mouth-gut discordance), (2) To determine whether individual differences in sensory perception influence expected or post-ingestive satiety.
Stage 1, Characterising Volunteers:
Fat is perceived through three sensory modalities; mouthfeel, taste and odour. Humans vary in their perception of fat across all sensory modalities. Volunteers will be characterised on their ability to taste fatty acids and perceive mouthfeel.
Stage 2, Establish Sensory Tolerance in Expected Satiety of a fat reduced snack model:
Reduced fat products are typically reformulated to match the perceived texture and mouthfeel of the original product. This stage aims to quantify sensory tolerance to fat reduction.
Stage 3, Establish Mouth Gut Discordance of a fat reduced snack model:
Using a standard preload study design, and the same fat-emulsion snack model from stage 2, the investigators will contrast effects of 3 test samples in a balanced cross-over design.
- Being tested
- Expanded Corn Snack
- Keywords
- Fat, Oral sensitivity, Appetite, Metabolism
- Medical subject headings
- Appetitive Behavior, Food Intolerance, Food Preferences, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Corn SnackBehavioural
A standard expanded snack will be used in each of the 3 arms, the content and type of fat added to the snack is varied in the two experimental arms.
| Study group | Role | What they receive |
|---|---|---|
| Positive Control (standard fat) | Active comparator | Expanded Corn Snack. Positive control (13 g oil per 40 g snack portion) Receives: Behavioral: Expanded Corn Snack |
| Negative Control (reduced fat) | Experimental | Expanded Corn Snack. Negative control (<8 g oil per 40 g snack) Receives: Behavioral: Expanded Corn Snack |
| Reduced Fat Sensory Matched | Experimental | Expanded Corn Snack. Reduced fat optimised (<8 g oil, matched sensory signals) Receives: Behavioral: Expanded Corn Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake (gram)
Weighed food intake (gram) at ad libitum meal
Measured: One measurement taken at 240 min after start of each stage 3 visit day.
Secondary outcomes (16)
Satiety hormone Cholecystokinin (CCK)
Cholecystokinin (CCK) is one of the satiety hormones, a peptide hormone of the gastrointestinal system responsible for stimulating the digestion of fat and modulating appetite. Blood sample will be collected in order to analyze the level (pg/ml) of cholecystokinin (CCK).
Measured: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Peptide YY (PYY)
Peptide YY (PYY) is one of the satiety hormones, acting to reduce appetite. Blood sample will be collected in order to analyze the level (pg/ml) of Peptide YY (PYY).
Measured: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Glucagon-like peptide-1 (GLP-1)
Glucagon-like peptide-1 (GLP-1) is one of the satiety hormones, modulating appetite. Blood sample will be collected in order to analyze the level (pg/ml) of Glucagon-like peptide-1 (GLP-1).
Measured: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Ghrelin
Ghrelin is termed as the 'hunger hormone' as it stimulates appetite, increases food intake and promotes fat storage. Blood sample will be collected in order to analyze the level (pg/ml) of Ghrelin.
Measured: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Leptin
Leptin is a hormone that can regulate energy intake and modulate hunger. Blood sample will be collected in order to analyze the level (pg/ml) of Leptin.
Measured: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Gastric inhibitory polypeptide (GIP)
Gastric inhibitory polypeptide (GIP) can modulate appetite. Blood sample will be collected in order to analyze the level (pg/ml) of Gastric inhibitory polypeptide (GIP).
Measured: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Saliva Samples
The level (ppm) of metabolomics (e.g. butyrate, propionate, lactate, acetate and 3-hydroxyisovalerate) in un-stimulated saliva will be analyzed using Nuclear Magnetic Resonance (NMR). As all these metabolomics in saliva can be analysed in one run, this is treated as one outcome.
Measured: Samples at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Urine Samples
Sample for urinary Nuclear Magnetic Resonance (NMR) metabolic profiles. Spectra will be compared and differences in integrated peak areas compared as AU (arbitrary units)
Measured: One sample at start of study day (0 min) and one sample at start of lunch (180 min) on each stage 3 visit day
Satiety Ratings
Satiety Ratings on visual analogue unstructured line scale (from 0 (not at all) to 100 (extremely)). The score obtained from participants only represents the hunger or satiety at that time point, which does not represent "good" or "bad" outcome.
Measured: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
Hunger Ratings
Hunger Ratings on visual analogue unstructured line scale (from 0 (not at all) to 100 (extremely)). The score obtained from participants only represents the hunger or satiety at that time point, which does not represent "good" or "bad" outcome.
Measured: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
Individual differences in sensory perception (fatty acid sensitivity)
Volunteers will have been characterised on their ability to taste the emulsions samples with the added fatty acid at the level of 0.016% and 0.11% (weight by weight) in Stage 1 (in the first visit). A discrimination forced choice test will be used, where the participant is asked to state the odd sample out of a set. If they can detect fatty acid in the samples correctly three times, they will be classified as hyper-sensitivity, otherwise they will be classified as hypo-sensitivity.
Measured: Sensory perception measures taken once in stage 1 (in the first visit of the study)
Individual differences in sensory perception (Mouthfeel Sensitivity)
A mouthfeel discrimination test will be carried out using savoury biscuits which are constant in overall fat content but vary in mouthfeel characteristics. Four samples will be prepared varying in mouthfeel and participants will be asked to taste the samples and then rate them for the mouthfeel attributes of Crunchiness, Hardness, Greasiness, on visual analogue structured line scale (from 0 (not at all) to 100 (extremely)).
Measured: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in sensory perception (Tactile sensitivity )
Von Frey filaments will be used to evaluate tactile sensitivity on the tongue, and to relate this to taste sensitivity. Participants will be asked to wear a blindfold, the middle of their tongue is then either stimulated or not stimulated with two Von Frey filaments of 0.008g and 0.02g sizes. The participant responds to say whether they have felt the stimulation and how sure they are (signal sure, signal not sure, no signal sure, no signal not sure). This is repeated 10 times in rapid succession. Responses are analysed using an R-index (%) value which is standard for a signal-noise detection test.
Measured: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in sensory perception (Mouth behaviour test )
A simple short questionnaire will be used, which has been validated in the USA, to categorise people as "Crunchers", "Chewers", "Suckers" and "Smooshers". Whereas "Chewers" tend to chew foods to a fine particle size before swallowing, "Crunchers" rapidly crunch and swallow. This questionnaire has been validated in the United States.
Measured: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in sensory perception (Fungiform papillae (FP) density)
In order to determine fungiform papillae density on the tongue, a digital camera will be used to record an image of the number of fungiform papillae in two one cm2 areas of the tongue. A small area of the participant's tongue will be temporarily dyed blue using food colour applied by a cotton wool bud. The tongue will then be blotted dry to remove excess moisture prior to recording a digital image. The blue colour will fade after approximately 1 hour and the extent of the colouration is similar to eating certain coloured sweets (e.g. blue Smarties).The number of the fungiform papillae (FP) density will be counted afterwards and quantified as papillae / cm square.
Measured: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in expected satiety
7 snack samples will be presented to subjects in a monadic sequential manner (i.e. one at a time) in a balanced order. After tasting each sample, participants will rate expected satiety ( "If you were to consume a full portion of this product, how full do you think you would feel?"and "How long do you think it would be before you felt hungry again?"). Visual analogue unstructured line scales (from 0 (not at all) to 100 (extremely)) will be used.
Measured: Expected satiety measures taken once in stage 2 (in the second visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start2 Jul 2018
- Primary completion11 Apr 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 3 way crossover design using a pre-load study protocol that is standard for behavioural appetite studies. The study will be conducted single-blind, as it is not feasible to blind the researcher to the pre-load food products. Each participant will attend 3 visits, the pre-load study foods will be presented to them with random blinding codes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sussex, Quadram Institute Bioscience, Unilever R&D, PepsiCo Global R&D, Mondelēz International, Inc., Arla Foods, Mars, Inc.
- Responsible party
- Principal investigator, Lisa Methven, University of Reading
- Investigators
- Lisa Methven, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585920
- Sponsor's protocol ID
- UREC 18/05
- Status last verified
- Feb 2020
- First submitted
- 14 Jun 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unlinked / non-identifiable) data will be useful in a meta-analysis and, hence, sharing individual participant data (IPD) will be considered.
Publications
Zhou X, Shen Y, Parker JK, Kennedy OB, Methven L. Relative Effects of Sensory Modalities and Importance of Fatty Acid Sensitivity on Fat Perception in a Real Food Model. Chemosens Percept. 2016;9:105-119. doi: 10.1007/s12078-016-9211-5. Epub 2016 Jul 11.
PubMed 27594969Stewart JE, Newman LP, Keast RS. Oral sensitivity to oleic acid is associated with fat intake and body mass index. Clin Nutr. 2011 Dec;30(6):838-44. doi: 10.1016/j.clnu.2011.06.007. Epub 2011 Jul 14.
PubMed 21757270Lett AM, Norton JE, Yeomans MR. Emulsion oil droplet size significantly affects satiety: A pre-ingestive approach. Appetite. 2016 Jan 1;96:18-24. doi: 10.1016/j.appet.2015.08.043. Epub 2015 Sep 4.
PubMed 26344811Woodend DM, Anderson GH. Effect of sucrose and safflower oil preloads on short term appetite and food intake of young men. Appetite. 2001 Dec;37(3):185-95. doi: 10.1006/appe.2001.0425.
PubMed 11895319Yeomans MR, Chambers L. Satiety-relevant sensory qualities enhance the satiating effects of mixed carbohydrate-protein preloads. Am J Clin Nutr. 2011 Dec;94(6):1410-7. doi: 10.3945/ajcn.111.011650. Epub 2011 Oct 26.
PubMed 22030223Keller KL, Liang LC, Sakimura J, May D, van Belle C, Breen C, Driggin E, Tepper BJ, Lanzano PC, Deng L, Chung WK. Common variants in the CD36 gene are associated with oral fat perception, fat preferences, and obesity in African Americans. Obesity (Silver Spring). 2012 May;20(5):1066-73. doi: 10.1038/oby.2011.374. Epub 2012 Jan 12.
PubMed 22240721Kulkarni BV, Mattes RD. Lingual lipase activity in the orosensory detection of fat by humans. Am J Physiol Regul Integr Comp Physiol. 2014 Jun 15;306(12):R879-85. doi: 10.1152/ajpregu.00352.2013. Epub 2014 Apr 2.
PubMed 24694384Mennella I, Savarese M, Ferracane R, Sacchi R, Vitaglione P. Oleic acid content of a meal promotes oleoylethanolamide response and reduces subsequent energy intake in humans. Food Funct. 2015 Jan;6(1):204-10. doi: 10.1039/c4fo00697f. Epub 2014 Oct 27.
PubMed 25347552Jeltema M, Beckley J, Vahalik J. Model for understanding consumer textural food choice. Food Sci Nutr. 2015 May;3(3):202-12. doi: 10.1002/fsn3.205. Epub 2015 Feb 2.
PubMed 25987995Yackinous C, Guinard JX. Relation between PROP taster status and fat perception, touch, and olfaction. Physiol Behav. 2001 Feb;72(3):427-37. doi: 10.1016/s0031-9384(00)00430-3.
PubMed 11274688Eldeghaidy S, Marciani L, Hort J, Hollowood T, Singh G, Bush D, Foster T, Taylor AJ, Busch J, Spiller RC, Gowland PA, Francis ST. Prior Consumption of a Fat Meal in Healthy Adults Modulates the Brain's Response to Fat. J Nutr. 2016 Nov;146(11):2187-2198. doi: 10.3945/jn.116.234104. Epub 2016 Sep 21.
PubMed 27655761
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
- ClinicalTrials.gov ID
- NCT03585920
- Acronym / sponsor ID
- UREC 18/05
- Keywords
- Fat, Oral sensitivity, Appetite, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- University of Sussex, Quadram Institute Bioscience, Unilever R&D, PepsiCo Global R&D, Mondelēz International, Inc., Arla Foods, Mars, Inc.
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 13 Jul 2018 (actual)
- 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 present study aims to investigate the effect of fat level and fat type of a snack on self-reported satiety and associated biomarkers. The relevant individual differences will also be investigated.
Detailed description
The aims are: (1) To determine whether reducing fat in a snack leads to rebound hunger and higher food intake at the subsequent meal, (2)To determine whether a low fat snack product matched for expected satiety leads to differences in post-ingestive satiety (i.e. mouth-gut discordance), (2) To determine whether individual differences in sensory perception influence expected or post-ingestive satiety.
Stage 1, Characterising Volunteers:
Fat is perceived through three sensory modalities; mouthfeel, taste and odour. Humans vary in their perception of fat across all sensory modalities. Volunteers will be characterised on their ability to taste fatty acids and perceive mouthfeel.
Stage 2, Establish Sensory Tolerance in Expected Satiety of a fat reduced snack model:
Reduced fat products are typically reformulated to match the perceived texture and mouthfeel of the original product. This stage aims to quantify sensory tolerance to fat reduction.
Stage 3, Establish Mouth Gut Discordance of a fat reduced snack model:
Using a standard preload study design, and the same fat-emulsion snack model from stage 2, the investigators will contrast effects of 3 test samples in a balanced cross-over design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a 3 way crossover design using a pre-load study protocol that is standard for behavioural appetite studies. The study will be conducted single-blind, as it is not feasible to blind the researcher to the pre-load food products. Each participant will attend 3 visits, the pre-load study foods will be presented to them with random blinding codes.
| Arm | Type | Receives |
|---|---|---|
| Positive Control (standard fat) | Active comparator | Behavioral: Expanded Corn SnackExpanded Corn Snack. Positive control (13 g oil per 40 g snack portion) |
| Negative Control (reduced fat) | Experimental | Behavioral: Expanded Corn SnackExpanded Corn Snack. Negative control (<8 g oil per 40 g snack) |
| Reduced Fat Sensory Matched | Experimental | Behavioral: Expanded Corn SnackExpanded Corn Snack. Reduced fat optimised (<8 g oil, matched sensory signals) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women
- Aged 18-70 years
- Body mass index (BMI): 18-32 kg/m2
- Fasting glucose < 7 mmol/l
- Fasting total cholesterol < 7.5 mmol/L
Key exclusion criteria (10 listed)
- Diagnosed with diabetes or cardiovascular disease (e.g. stroke or heart attack), gastrointestinal (e.g. Irritable bowel syndrome (IBS), inflammatory conditions, gastroenteritis), endocrine or renal diseases
- Smoker
- Taking prescribed medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
- Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose)
- Drug abuse
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 |
|---|---|---|
| Expanded Corn SnackA standard expanded snack will be used in each of the 3 arms, the content and type of fat added to the snack is varied in the two experimental arms. | Behavioural | Negative Control (reduced fat), Positive Control (standard fat), Reduced Fat Sensory Matched |
Primary outcome
Food Intake (gram)
Time frame: One measurement taken at 240 min after start of each stage 3 visit day.
Weighed food intake (gram) at ad libitum meal
16 secondary outcomes
Satiety hormone Cholecystokinin (CCK)
Time frame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Peptide YY (PYY)
Time frame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Glucagon-like peptide-1 (GLP-1)
Time frame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Ghrelin
Time frame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Leptin
Time frame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Satiety hormone Gastric inhibitory polypeptide (GIP)
Time frame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Saliva Samples
Time frame: Samples at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Urine Samples
Time frame: One sample at start of study day (0 min) and one sample at start of lunch (180 min) on each stage 3 visit day
Satiety Ratings
Time frame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
Hunger Ratings
Time frame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
Individual differences in sensory perception (fatty acid sensitivity)
Time frame: Sensory perception measures taken once in stage 1 (in the first visit of the study)
Individual differences in sensory perception (Mouthfeel Sensitivity)
Time frame: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in sensory perception (Tactile sensitivity )
Time frame: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in sensory perception (Mouth behaviour test )
Time frame: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in sensory perception (Fungiform papillae (FP) density)
Time frame: Sensory perception measures taken once in stage 1 (in the first visit).
Individual differences in expected satiety
Time frame: Expected satiety measures taken once in stage 2 (in the second visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 27594969Zhou X, Shen Y, Parker JK, Kennedy OB, Methven L. Relative Effects of Sensory Modalities and Importance of Fatty Acid Sensitivity on Fat Perception in a Real Food Model. Chemosens Percept. 2016;9:105-119. doi: 10.1007/s12078-016-9211-5. Epub 2016 Jul 11.
- Background: PubMed 21757270Stewart JE, Newman LP, Keast RS. Oral sensitivity to oleic acid is associated with fat intake and body mass index. Clin Nutr. 2011 Dec;30(6):838-44. doi: 10.1016/j.clnu.2011.06.007. Epub 2011 Jul 14.
- Background: PubMed 26344811Lett AM, Norton JE, Yeomans MR. Emulsion oil droplet size significantly affects satiety: A pre-ingestive approach. Appetite. 2016 Jan 1;96:18-24. doi: 10.1016/j.appet.2015.08.043. Epub 2015 Sep 4.
- Background: PubMed 11895319Woodend DM, Anderson GH. Effect of sucrose and safflower oil preloads on short term appetite and food intake of young men. Appetite. 2001 Dec;37(3):185-95. doi: 10.1006/appe.2001.0425.
- Background: PubMed 22030223Yeomans MR, Chambers L. Satiety-relevant sensory qualities enhance the satiating effects of mixed carbohydrate-protein preloads. Am J Clin Nutr. 2011 Dec;94(6):1410-7. doi: 10.3945/ajcn.111.011650. Epub 2011 Oct 26.
- Background: PubMed 22240721Keller KL, Liang LC, Sakimura J, May D, van Belle C, Breen C, Driggin E, Tepper BJ, Lanzano PC, Deng L, Chung WK. Common variants in the CD36 gene are associated with oral fat perception, fat preferences, and obesity in African Americans. Obesity (Silver Spring). 2012 May;20(5):1066-73. doi: 10.1038/oby.2011.374. Epub 2012 Jan 12.
- Background: PubMed 24694384Kulkarni BV, Mattes RD. Lingual lipase activity in the orosensory detection of fat by humans. Am J Physiol Regul Integr Comp Physiol. 2014 Jun 15;306(12):R879-85. doi: 10.1152/ajpregu.00352.2013. Epub 2014 Apr 2.
- Background: PubMed 25347552Mennella I, Savarese M, Ferracane R, Sacchi R, Vitaglione P. Oleic acid content of a meal promotes oleoylethanolamide response and reduces subsequent energy intake in humans. Food Funct. 2015 Jan;6(1):204-10. doi: 10.1039/c4fo00697f. Epub 2014 Oct 27.
- Background: PubMed 25987995Jeltema M, Beckley J, Vahalik J. Model for understanding consumer textural food choice. Food Sci Nutr. 2015 May;3(3):202-12. doi: 10.1002/fsn3.205. Epub 2015 Feb 2.
- Background: PubMed 11274688Yackinous C, Guinard JX. Relation between PROP taster status and fat perception, touch, and olfaction. Physiol Behav. 2001 Feb;72(3):427-37. doi: 10.1016/s0031-9384(00)00430-3.
- Background: PubMed 27655761Eldeghaidy S, Marciani L, Hort J, Hollowood T, Singh G, Bush D, Foster T, Taylor AJ, Busch J, Spiller RC, Gowland PA, Francis ST. Prior Consumption of a Fat Meal in Healthy Adults Modulates the Brain's Response to Fat. J Nutr. 2016 Nov;146(11):2187-2198. doi: 10.3945/jn.116.234104. Epub 2016 Sep 21.
- Individual participant dataSharing planned: No. No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unlinked / non-identifiable) data will be useful in a meta-analysis and, hence, sharing individual participant data (IPD) will be considered.
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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.
Lisa Methven principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Corn Snack in people with Appetitive Behavior and Individual Difference, run by University of Reading 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 12 Feb 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Intake (gram) (time frame: One measurement taken at 240 min after start of each stage 3 visit day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585920, which also lists 11 linked publications.
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 Feb 2020.