NCT03585920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

June 14, 2018

Last Update Submit

February 11, 2020

Conditions

Appetitive BehaviorIndividual DifferenceFood SensitivityFood Preferences

Keywords

FatOral sensitivityAppetiteMetabolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Satiety hormone 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)

    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)

    Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.

  • Satiety hormone Ghrelin

    Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.

  • Satiety hormone Leptin

    Sampled via cannula at 0, 15, 105, 125, 155, 180 and 240 min on each stage 3 visit day.

  • +11 more secondary outcomes

Study Arms (3)

Positive Control (standard fat)

ACTIVE COMPARATOR

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

Behavioral: Expanded Corn Snack

Negative Control (reduced fat)

EXPERIMENTAL

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

Behavioral: Expanded Corn Snack

Reduced Fat Sensory Matched

EXPERIMENTAL

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

Behavioral: Expanded Corn Snack

Interventions

Expanded Corn SnackBEHAVIORAL

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.

Negative Control (reduced fat)Positive Control (standard fat)Reduced Fat Sensory Matched

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Reading, Berkshire, RG6 6UR, United Kingdom

Location

Related Publications (11)

  • 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. doi: 10.1007/s12078-016-9211-5. Epub 2016 Jul 11.

    PMID: 27594969BACKGROUND

  • 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.

    PMID: 21757270BACKGROUND

  • 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.

    PMID: 26344811BACKGROUND

  • 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. doi: 10.1006/appe.2001.0425.

    PMID: 11895319BACKGROUND

  • 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.

    PMID: 22030223BACKGROUND

  • 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.

    PMID: 22240721BACKGROUND

  • 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.

    PMID: 24694384BACKGROUND

  • 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.

    PMID: 25347552BACKGROUND

  • 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.

    PMID: 25987995BACKGROUND

  • Yackinous C, Guinard JX. Relation between PROP taster status and fat perception, touch, and olfaction. Physiol Behav. 2001 Feb;72(3):427-37. doi: 10.1016/s0031-9384(00)00430-3.

    PMID: 11274688BACKGROUND

  • 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. doi: 10.3945/jn.116.234104. Epub 2016 Sep 21.

    PMID: 27655761BACKGROUND

MeSH Terms

Conditions

Appetitive BehaviorFood IntoleranceFood PreferencesPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding Behavior

Study Officials

  • Lisa Methven

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All samples provided to the participant are labelled with 3 digit random codes.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Food and Sensory Science

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 13, 2018

Study Start

July 2, 2018

Primary Completion

April 11, 2019

Study Completion

October 25, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)