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

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ClinicalTrials.gov Identifier: NCT03585920
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
University of Sussex
Quadram Institute Bioscience
Unilever R&D
PepsiCo Global R&D
Mondelēz International, Inc.
Arla Foods
Mars, Inc.
Information provided by (Responsible Party):
Lisa Methven, University of Reading

Brief 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.

Condition or disease Intervention/treatment Phase
Appetitive Behavior Individual Difference Food Sensitivity Food Preferences Behavioral: Expanded Corn Snack Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant)
Masking Description: All samples provided to the participant are labelled with 3 digit random codes.
Primary Purpose: Prevention
Official Title: The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Active Comparator: Positive Control (standard fat)
Expanded Corn Snack. Positive control (13 g oil per 40 g snack portion)
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.

Experimental: Negative Control (reduced fat)
Expanded Corn Snack. Negative control (<8 g oil per 40 g snack)
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.

Experimental: Reduced Fat Sensory Matched
Expanded Corn Snack. Reduced fat optimised (<8 g oil, matched sensory signals)
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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)

  9. Satiety Ratings [ Time Frame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day. ]
    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.

  10. Hunger Ratings [ Time Frame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day. ]
    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.

  11. 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.

  12. 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)).

  13. 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.

  14. 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.

  15. 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.

  16. Individual differences in expected satiety [ Time Frame: Expected satiety measures taken once in stage 2 (in the second visit). ]
    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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585920


Contacts
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Contact: Lisa Methven +44(0) 118 378 8714 l.methven@reading.ac.uk
Contact: Xirui Zhou x.zhou@reading.ac.uk

Locations
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United Kingdom
Sensory Science Centre, Department of Food and Nutritional Science, University of Reading Recruiting
Reading, Berkshire, United Kingdom, RG6 6UR
Contact: Lisa Methven         
Contact: Xirui Zhou         
Sponsors and Collaborators
University of Reading
University of Sussex
Quadram Institute Bioscience
Unilever R&D
PepsiCo Global R&D
Mondelēz International, Inc.
Arla Foods
Mars, Inc.
Investigators
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Principal Investigator: Lisa Methven University of Reading
  Study Documents (Full-Text)

Documents provided by Lisa Methven, University of Reading:

Publications:

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Responsible Party: Lisa Methven, Associate Professor in Food and Sensory Science, University of Reading
ClinicalTrials.gov Identifier: NCT03585920     History of Changes
Other Study ID Numbers: UREC 18/05
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lisa Methven, University of Reading:
Fat
Oral sensitivity
Appetite
Metabolism

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases