The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures

Healthy Subjects Clinical Trial

Official title:

The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097927
• Other study ID #: 127438-1
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: August 6, 2014
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Leatherhead Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Behavioral:
• Mango-flavour beverage
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 before and after repeated exposures to the beverages at home. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations.

Locations

Country	Name	City	State
United Kingdom	Leatherhead Food Research Nutrition Unit	Leatherhead	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Leatherhead Food Research	University of Sussex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers of appetite in saliva samples	Frozen saliva samples will be banked. On completion of the study saliva samples associating with the extremes of appetite rating or energy intake will be pooled (6-12 samples / pool) and the protein component analysed by quantitative proteomics using an isobaric tags for relative and absolute quantitation (iTRAQ) workflow. Remaining samples will be retained for validation of proteins found to associate or predict appetite or energy intake.	Weeks 0,3,5,8,10 and 13	No
Primary	Change in energy intake	Change in intake (kcals) at an ad libitum lunch, assessed before and after the repeated exposure period for each of the 3 beverage products	Weeks 0,3,5,8,10 and 13	No
Secondary	Change in subjective appetite ratings	Change in subjective feelings of appetite assessed with Visual Analogue Scales (VAS). These will be measured on each of the 6 test days, which will occur before and after the repeated exposure period for each of the 3 beverage products.	Weeks 0,3,5,8,10 and 13	No