Clinical trial NCT03585920: The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
Official title: The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Individual Difference
Food Sensitivity
Food Preferences
Keywords: Fat
Oral sensitivity
Appetite
Metabolism
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: University of Sussex
name: Quadram Institute Bioscience
name: Unilever R&D
name: PepsiCo Global R&D
name: Mondelēz International, Inc.
name: Arla Foods
name: Mars, Inc.
First posted: 2018-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Food Intake (gram)
timeFrame: One measurement taken at 240 min after start of each stage 3 visit day.
Secondary outcomes:
measure: Satiety hormone Cholecystokinin (CCK)
timeFrame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Satiety hormone Peptide YY (PYY)
timeFrame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Satiety hormone Glucagon-like peptide-1 (GLP-1)
timeFrame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Satiety hormone Ghrelin
timeFrame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Satiety hormone Leptin
timeFrame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Satiety hormone Gastric inhibitory polypeptide (GIP)
timeFrame: Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Saliva Samples
timeFrame: Samples at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.
measure: Urine Samples
timeFrame: One sample at start of study day (0 min) and one sample at start of lunch (180 min) on each stage 3 visit day
measure: Satiety Ratings
timeFrame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
measure: Hunger Ratings
timeFrame: Over 4 hours at time 0, 120, 150, 180 and 240 min on each stage 3 visit day.
measure: Individual differences in sensory perception (fatty acid sensitivity)
timeFrame: Sensory perception measures taken once in stage 1 (in the first visit of the study)
measure: Individual differences in sensory perception (Mouthfeel Sensitivity)
timeFrame: Sensory perception measures taken once in stage 1 (in the first visit).
measure: Individual differences in sensory perception (Tactile sensitivity )
timeFrame: Sensory perception measures taken once in stage 1 (in the first visit).
measure: Individual differences in sensory perception (Mouth behaviour test )
timeFrame: Sensory perception measures taken once in stage 1 (in the first visit).
measure: Individual differences in sensory perception (Fungiform papillae (FP) density)
timeFrame: Sensory perception measures taken once in stage 1 (in the first visit).
measure: Individual differences in expected satiety
timeFrame: Expected satiety measures taken once in stage 2 (in the second visit).
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Sensory Science Centre, Department of Food and Nutritional Science, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Lisa Methven
role: PRINCIPAL_INVESTIGATOR
References:
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