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

February 11, 2020 updated by: Lisa Methven, University of Reading
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.

Study Overview

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6UR
        • Sensory Science Centre, Department of Food and Nutritional Science, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
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.
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).
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).
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.
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).
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).
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.
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

April 11, 2019

Study Completion (Actual)

October 25, 2019

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC 18/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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