The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks

Appetitive Behavior Clinical Trial

Official title:

The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585920
• Other study ID #: UREC 18/05
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: October 25, 2019

Study information

• Verified date: February 2020
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 25, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Food Preferences
• Food Sensitivity
• Hypersensitivity
• Individual Difference

Intervention

Behavioral:
• Expanded Corn 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.

Locations

Country	Name	City	State
United Kingdom	Sensory Science Centre, Department of Food and Nutritional Science, University of Reading	Reading	Berkshire

Sponsors (8)

Lead Sponsor	Collaborator
University of Reading	Arla Foods, Mars, Inc., Mondelez International, Inc., PepsiCo Global R&D, Quadram Institute Bioscience, Unilever R&D, University of Sussex

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

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. Epub 2016 Sep 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yackinous C, Guinard JX. Relation between PROP taster status and fat perception, touch, and olfaction. Physiol Behav. 2001 Feb;72(3):427-37. — View Citation

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. — View Citation

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. Epub 2016 Jul 11. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Intake (gram)	Weighed food intake (gram) at ad libitum meal	One measurement taken at 240 min after start of each stage 3 visit day.
Secondary	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).	Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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).	Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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).	Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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.	Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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.	Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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).	Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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.	Samples at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
Secondary	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)	One sample at start of study day (0 min) and one sample at start of lunch (180 min) on each stage 3 visit day
Secondary	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.	Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
Secondary	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.	Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
Secondary	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.	Sensory perception measures taken once in stage 1 (in the first visit of the study)
Secondary	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)).	Sensory perception measures taken once in stage 1 (in the first visit).
Secondary	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.	Sensory perception measures taken once in stage 1 (in the first visit).
Secondary	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.	Sensory perception measures taken once in stage 1 (in the first visit).
Secondary	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.	Sensory perception measures taken once in stage 1 (in the first visit).
Secondary	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.	Expected satiety measures taken once in stage 2 (in the second visit).