- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585920
The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Berkshire
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Reading, Berkshire, United Kingdom, RG6 6UR
- Sensory Science Centre, Department of Food and Nutritional Science, University of Reading
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Positive Control (standard fat)
Expanded Corn Snack.
Positive control (13 g oil per 40 g snack portion)
|
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.
|
Experimental: Negative Control (reduced fat)
Expanded Corn Snack.
Negative control (<8 g oil per 40 g snack)
|
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.
|
Experimental: Reduced Fat Sensory Matched
Expanded Corn Snack.
Reduced fat optimised (<8 g oil, matched sensory signals)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One measurement taken at 240 min after start of each stage 3 visit day.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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).
|
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.
|
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).
|
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.
|
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).
|
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.
|
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.
|
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.
|
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.
|
Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
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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.
|
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).
|
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.
|
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.
|
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
|
Sample for urinary Nuclear Magnetic Resonance (NMR) metabolic profiles.
Spectra will be compared and differences in integrated peak areas compared as AU (arbitrary units)
|
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.
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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.
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Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
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Hunger Ratings
Time Frame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
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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.
|
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)
|
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.
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Sensory perception measures taken once in stage 1 (in the first visit of the study)
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Individual differences in sensory perception (Mouthfeel Sensitivity)
Time Frame: Sensory perception measures taken once in stage 1 (in the first visit).
|
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)).
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Sensory perception measures taken once in stage 1 (in the first visit).
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Individual differences in sensory perception (Tactile sensitivity )
Time Frame: Sensory perception measures taken once in stage 1 (in the first visit).
|
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.
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Sensory perception measures taken once in stage 1 (in the first visit).
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Individual differences in sensory perception (Mouth behaviour test )
Time Frame: Sensory perception measures taken once in stage 1 (in the first visit).
|
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.
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Sensory perception measures taken once in stage 1 (in the first visit).
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Individual differences in sensory perception (Fungiform papillae (FP) density)
Time Frame: Sensory perception measures taken once in stage 1 (in the first visit).
|
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.
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Sensory perception measures taken once in stage 1 (in the first visit).
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Individual differences in expected satiety
Time Frame: Expected satiety measures taken once in stage 2 (in the second visit).
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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.
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Expected satiety measures taken once in stage 2 (in the second visit).
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Collaborators and Investigators
Publications and helpful links
General 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.
- Stewart 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.
- Lett 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.
- Woodend 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.
- Yeomans 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.
- Keller 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.
- Kulkarni 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.
- Mennella 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.
- Jeltema 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.
- Yackinous 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.
- Eldeghaidy 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UREC 18/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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