Clinical trial NCT02097927: The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures
Official title: The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Appetite
Satiety
Energy intake
Saliva
Biomarkers
Lead sponsor: Leatherhead Food Research
Sponsor class: INDUSTRY
Collaborators: name: University of Sussex
First posted: 2014-03-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control.

In addition, saliva samples will be collected at regular intervals for the identification of novel biomarkers of energy intake.

Detailed description: The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions (plus one screening visit) before and after repeated exposures to the beverages at home. The order in which participants receive the beverages will be counterbalanced and randomised. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations. Participants will fast overnight before each visit and consume the same evening meal before each test day. Participants will be instructed to avoid consuming food or calorific beverages for one hour before or after consuming the beverage. Following the last satiety testing day participants will be debriefed and open questions will be asked about experiences of the beverages in a focus group format.

Eligibility criteria: Inclusion Criteria:

* Gender: male or female
* Age at start of the study ≥ 18 and ≤ 65 years
* Body Mass Index (BMI) ≥ 18 and ≤ 29.9 kg/m2
* Apparently healthy: measured by questionnaire (APPENDIX 3): no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤14 units/w
* Informed consent signed
* Recruitment form filled out

Exclusion Criteria:

* Smoking
* Dislike, allergy or intolerance to test products or study meals
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Reported medical treatment that may affect eating habits/satiety
* Eating habits questionnaire score \>14
* Reported participation in another biomedical trial 1 month before the start of the study
* Food allergies or intolerance to ad libitum meals
* Pregnant and/or breast feeding

Primary outcomes:
measure: Change in energy intake
timeFrame: Weeks 0,3,5,8,10 and 13
Secondary outcomes:
measure: Change in subjective appetite ratings
timeFrame: Weeks 0,3,5,8,10 and 13
Other outcomes:
measure: Biomarkers of appetite in saliva samples
timeFrame: Weeks 0,3,5,8,10 and 13
Locations:
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food Research Nutrition Unit
state: Surrey
Study officials:
affiliation: Leatherhead Food Research
name: Roberta Re, PhD
role: STUDY_DIRECTOR
References: