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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Behavioral: Mango-flavour beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Leatherhead, Surrey, United Kingdom, KT22 7RY
      • Leatherhead Food Research Nutrition Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High energy, low sensory; Mango-flavour beverage	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.
Experimental: Low energy, high sensory; Mango-flavour beverage	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.
Experimental: High energy, high sensory beverage; Mango-flavour beverage	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Leatherhead Food Research
• Collaborators: University of Sussex
• Investigators: Study Director: Roberta Re, PhD, Leatherhead Food Research

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Estimate): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Biomarkers; Saliva; Satiety; Appetite; Energy intake
• Other Study ID Numbers: 127438-1