Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/09/2014
Date assigned
24/10/2014
Last edited
28/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Locust bean gum is a soluble fibre that increases food viscosity (making it thicker, for example, or less easy to pour). It takes a long time to be digested which means it has the potential to make people feel fuller and more satisfied for longer after eating a meal (increased satiety) without the need to provide more food with more calories. The effects of locust bean gum on satiety may be related to its effects (delay) on gastric emptying (the amount of time it takes for food to be taken from the stomach into the small intestine). We want to look at how locust bean gum (viscogum) added to a fishball meal might affect how much people eat of the meal, how quickly they eat it, how full they feel afterwards and how much they eat at their next meal.

Who can participate?
Adult females aged between 18-55 that are either overweight or obese, with a body mass index (BMI) of 27.0 – 31.9.kg/m2.

What does the study involve?
Participants are asked to attend two full testing days. For both days they eat a breakfast, a fixed lunch (the fishball meal) and a dinner of which they can eat as much as they like in the University of Liverpool's eating behaviour laboratory (Kissileff Laboratory). Each participant is randomly allocated to eat either a fishball meal with the viscogum added or a “control” fishball meal (which doesn’t include the viscogum) on their first visit. They then have a break from the testing for a week (referred to as a wash out period) before coming back to the laboratory to eat their second meal. Participants who ate the fishball meal with the viscogum on their first visit are given the control fishball meal on their second visit and vice versa. Each participant is also asked to attend screening and testing sessions, which includes filling in a series of questionnaires and measuring their height and weight, before coming in for the two full testing days.

What are the possible benefits and risks of participating?
There are no direct benefits to participating but knowledge gained will help to better understand what kind of foods may help people control their weight. All the foods used in the study are either commonly available or specifically developed to be eaten from a combination of commonly available foods with extensive food safety tests and are cooked in a conventional manner. Viscogum (guar gum) comes from the from the Carob plant, a natural source used in modern food processing. In the unlikely event of an emergency, The Kissileff Laboratory has dedicated first-aiders and an emergency procedure is in place should this be necessary.

Where is the study run from?
The Kissileff Laboratory in the University of Liverpool (UK)

Who is funding the study?
The University of Liverpool as part of the European Union funded Satiety Innovation (SATIN) Grant (UK)

Who is the main contact?
Dr. Joanne Harrold (harrold@liverpool.ac.uk)
Prof. Jason Halford (j.c.g.halford@liverpool.ac.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanne Harrold

ORCID ID

Contact details

Room 2.30a
Department of Psychological Sciences
Eleanor Rathbone Building
Bedford Street South
University of Liverpool
Liverpool
L69 7ZA
United Kingdom
+ 44 (0)151 794 1136
harrold@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Experimental study to investigate the acute effect of a fishball meal enriched with locust bean gum (Viscogum) on food intake and the experience of appetite.

Acronym

Study hypothesis

To investigate the impact of a fishball meal with (experimental) or without (control) a soluble fibre (Viscogum) on food intake, feeding behaviour and experience of appetite in female volunteers with a BMI of 27-31.9 kg/m2

Ethics approval

Liverpool Committee of Research Ethics, 24/07/2014, ref: RETH000565

Study design

Randomized crossover within subjects design with two conditions

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Effects of a soluble fibre type on appetite to inform about future weight interventions/obesity

Intervention

The study will involve 34 female participants attending the Kissileff Laboratory on two study day visits in which they will receive the active (viscogum guar gum) fishball meal for lunch on one day and a control (placebo) fishball meal on a separate day. Participation will include a 1-week wash out period between visits. All participants will undergo both conditions which will be randomized using a Latin Square design.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To demonstrate:
1. Reductions in eating rate at a fixed load meal including consumption of viscogum containing fishballs in comparison to control (calculated as grams consumed per minute)
2. Reductions in caloric intake at a subsequent ad libitum meal following consumption of viscogum containing fishballs in comparison to control (measuring food intake - grams/calories consumed)
3. 24 hour reduction in caloric intake in ad-libitum meals following consumption of viscogum containing fishballs in comparison to control (measuring food intake - grams/calories consumed)

Secondary outcome measures

To investigate:
1. Changes in within meal satiation during ingestion of viscogum containing fishballs compared to control using Visual Analogue Scale (VAS) appetite measures (hunger, fullness, prospective consumption, desire to eat)
2. Changes in meal duration of a fixed load meal including viscogum containing fishballs compared to control (measuring time of intake during the meal)
3. Changes in macronutrient intake and duration of a subsequent ad libitum meal following consumption of viscogum containing fishballs compared to control
4. Subjective experience of appetite and snack palatability using Visual Analogue Scale (VAS) measures

Overall trial start date

25/08/2014

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants having given written consent to take part in the study
2. Healthy female participants aged 18 to 55 years
3. BMI of 27.0 – 31.9 kg/m2
4. Not dieting within the last month or having lost a significant amount of weight over the previous 6 months
5. Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
6. Non-smokers
7. Able to eat most everyday foods
8. Consume fish products
9. Breakfast eaters

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

34

Participant exclusion criteria

1. Those with significant health problems
2. BMI < 27.0 kg/m2 or > 31.9 kg/m2
3. Participants who self-report dieting currently or within the last month or having lost a significant amount of weight over the previous 6 months
4. Volunteers who have significantly changed their physical activity patterns in the past 2-4 weeks or who intend to change them during the study
5. Gastrointestinal symptoms requiring treatment
6. Smokers or those who have recently ceased smoking (including electric cigarettes)
7. Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
8. Pregnant or planning to become pregnant during the study; breast-feeding (self-reported)
9. Participants with a history of anaphylaxis (allergic reactions) to foods
10. Participants who work in the following areas: Nutrition, Dietetics, Food Research, Food Manufacturing or Supplements Industry
11. Participants currently adhering to any specific food avoidance diets such as Atkins, the South Beach diet or low Glycaemic Index (GI)
12. Participants who have had bariatric surgery for weight control or other reason
13. Non breakfast eaters
14. Post-menopausal participants
15. Those reporting a history of anaphylaxis to food, significant general food allergies or specific allergies to any of the study foods
16. Participants with abnormal eating behaviour

Recruitment start date

25/08/2014

Recruitment end date

01/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room 2.30a
Liverpool
L69 7ZA
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Professor Jason Halford
Room 2.17
Eleanor Rathbone Building
Bedford Street South
University of Liverpool
Liverpool
L69 7ZA
United Kingdom

Sponsor type

University/education

Website

http://www.satin-satiety.eu/

Funders

Funder type

University/education

Funder name

University of Liverpool as part of the European Union funded Satiety Innovation (SATIN) Grant (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes