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

NCT ID: NCT02097927

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-08-31

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High energy, low sensory

Mango-flavour beverage

Group Type: EXPERIMENTAL

Mango-flavour beverage

Intervention Type: BEHAVIORAL

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.

Low energy, high sensory

Mango-flavour beverage

Group Type: EXPERIMENTAL

Mango-flavour beverage

Intervention Type: BEHAVIORAL

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.

High energy, high sensory beverage

Mango-flavour beverage

Group Type: EXPERIMENTAL

Mango-flavour beverage

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sussex

OTHER

Sponsor Role: collaborator

Leatherhead Food Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberta Re, PhD

Role: STUDY_DIRECTOR

Leatherhead Food Research

Locations

Leatherhead Food Research Nutrition Unit

Leatherhead, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

127438-1

Identifier Type: -

Identifier Source: org_study_id