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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03585920
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Reading
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lisa Methven
Principal Investigator Affiliation	University of Reading
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Appetitive Behavior, Individual Difference, Food Sensitivity, Food Preferences

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Positive Control (standard fat)

Expanded Corn Snack. Positive control (13 g oil per 40 g snack portion)

Experimental: Negative Control (reduced fat)

Expanded Corn Snack. Negative control (<8 g oil per 40 g snack)

Experimental: Reduced Fat Sensory Matched

Expanded Corn Snack. Reduced fat optimised (<8 g oil, matched sensory signals)

Interventions

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.

Contact a Trial Team

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International Sites

Reading, Berkshire, United Kingdom

Status

Recruiting

Address

Sensory Science Centre, Department of Food and Nutritional Science, University of Reading

Reading, Berkshire, RG6 6UR

Site Contact

Lisa Methven

l.methven@reading.ac.uk

+44(0) 118 378 8714

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