Assessing a Polydextrose Containing Soup on Food Intake, NCT02258750

Clinical Trial Details — Status: Terminated

Administrative data
NCT number	NCT02258750
Other study ID #	ULKLSA002
Secondary ID
Status	Terminated
Phase	N/A
First received	September 25, 2014
Last updated	January 6, 2016
Start date	November 2014
Est. completion date	December 2015

Study information
Verified date	January 2016
Source	University of Liverpool
Contact	n/a
Is FDA regulated	No
Health authority	United Kingdom: Research Ethics Committee
Study type	Interventional

Clinical Trial Summary

This study will examine the impact of a soluble fibre (polydextrose) incorporated into a high fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers of satiation and satiety over 4-weeks. Specifically, the impact on the development of satiation within the fixed-load tomato soup containing the fibre, the development of satiety after the fixed-load meal containing fibre and intake at subsequent ad libitum meals will be examined as well as the insulin response and carbohydrate fermentation before and after 4-week dosing of the preload soup.

Description:

The science underpinning both short (episodic) and long (tonic) term appetite regulation demonstrates that foods higher in macronutrients such as fibre can, under certain experimental conditions, produce great decreases in feelings of hunger and increases in fullness, post consumption, compared to equi-caloric loads of high carbohydrate or high fat. Given that fibre increases the release of GLP-1, slows down gastric emptying, prolongs nutrient absorption and, over long-term use increases the generation of short chain fatty acids (SCFAs) which have been linked to improved satiety responding, it is plausible that it will produce strong effects on within meal processes of satiation and satiety over the short- and long-term. Fibre has also been suggested to influence carbohydrate fermentation (via generation of these SCFAs) and improve the insulin response, additionally improving satiety. Ingredients may be added to boost fibre content such as the use of polydextrose, which is a non-digestible polysaccharide usually used as a dietary fibre in foods. Polydextrose has also been shown to increase levels of SCFAs due to its slow fermentation and has been related to reductions in subsequent intake and/or reduced hunger.

The aim of the current study is to assess the impact of a high fibre, polydextrose enriched tomato soup (experimental) or a low fibre tomato soup (control) on food intake, the experience of appetite and biomarkers of satiation and satiety.

Sample size: 86 males aged between 18 and 55 years with a body mass index (BMI) of between 23.0 and 28.0 kg/m2. A subset of 28 participants will undergo additional finger prick blood glucose and hydrogen breath test measures to assess biomarkers of satiation and satiety. Power calculations to ensure sufficient participants are included were based on power expected for a medium effect (0.25) at 80% power for a 2 condition between-measures design using G*power.

Methods: Participants will be invited to three full test day (baseline control, session 1; first dosing, session 2; one day prior to final dosing, session 3) sessions in which they will be provided with breakfast (tailored to individual resting metabolic rate (RMR) using the Schofield equation), the preload condition (receiving a high fibre polydextrose enriched or control tomato soup) one hour before an ad-libitum lunch and followed four hours later by an ad-libitum dinner and snack box. All test days will involve the use of standard operating proceedures. Pre-packaged portions of soup will be provided for a 4-week dosing period between study sessions 2 and 3 for all participants.

A subset of participants (N=28) will additionally undergo 3 further testing sessions (baseline control, session 0; second dosing, session 3; final dosing, session 4) in which a breakfast will be provided followed by the test product with additional glucose and carbohydrate fermentation measures collected for 3 hours before a light fixed portion meal.

Throughout test days participants will complete visual analogue scales (VAS) for appetite and palatability as well as questionnaires pertaining to eating behaviour and current sensations (including a gastrointestinal distress questionnaire).

Statistical analysis: Primary analysis will be comparison of subsequent ad-libitum energy intake between high fibre polydextrose enriched tomato soup compared to control using ANOVA and post-hoc tests. Meal duration and various appetite ratings will also be analysed as will biomarkers of satiety. The specified participant numbers (n=86) give an 80% probability of detecting an effect on energy intake.

Recruitment information / eligibility
Status	Terminated
Enrollment	42
Est. completion date	December 2015
Est. primary completion date	December 2015
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Male
Age group	18 Years to 55 Years
Eligibility	Inclusion Criteria: - BMI of 23-28 kg/m2 - Not dieting within the last month and not having lost significant amount of weight in the previous year. - Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study - Able to eat most everyday foods - Breakfast eaters - Soup consumers - Written informed consent to be given Exclusion Criteria: - Those with significant health problems - BMI < 23.0 kg/m2 or > 28.0 kg/m2 - Participants who self-report dieting currently or within the last month or having lost a significant amount of weight over the previous 6 months. - Volunteers who have significantly changed their physical activity patterns in the past 2-4 weeks or who intend to change them during the study - Gastrointestinal symptoms requiring treatment. - Smokers or those who have recently ceased smoking (including electric cigarettes). - Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters. - Participants who work in the following areas: Nutrition, Dietetics, Food Research, Food Manufacturing or Supplements Industry. - Participants currently adhering to any specific food avoidance diets such as Atkins, the South Beach diet or low Glycaemic Index (GI). - Participants who have had bariatric surgery for weight control or other reason. - Non breakfast eaters. - Those reporting a history of anaphylaxis to food, significant general food allergies or specific allergies to any of the study foods. - Participants with abnormal eating behaviour

Study Design

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

Related Conditions & MeSH terms

Satiation, Satiety

Intervention

Dietary Supplement:
• Polydextrose
High fibre polydextrose enriched tomato soup (matched for sensory and nutritional characteristics to control) and eaten one hour before an ad-libitum lunch on study days. A 410g pre-packaged portion will be provided which contains 6% polydextrose compared to control.

Other:
• Control
Tomato soup (matched for sensory and nutritional characteristics to control) served in a 410g portion and eaten one hour before an ad-libitum lunch on study days.

Locations
Country	Name	City	State
United Kingdom	University of Liverpool	Liverpool	Merseyside

Sponsors *(1)*
Lead Sponsor	Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom,

References & Publications (4)

Flood MT, Auerbach MH, Craig SA. A review of the clinical toleration studies of polydextrose in food. Food Chem Toxicol. 2004 Sep;42(9):1531-42. Review. — View Citation

King NA, Craig SA, Pepper T, Blundell JE. Evaluation of the independent and combined effects of xylitol and polydextrose consumed as a snack on hunger and energy intake over 10 d. Br J Nutr. 2005 Jun;93(6):911-5. — View Citation

Ranawana V, Muller A, Henry CJ. Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males-a randomized controlled cross-over study. Eur J Nutr. 2013 Apr;52(3):885-93. doi: 10.1007/s00394-012-0395-4. Epub 2012 Jun 21. — View Citation

Schwab U, Louheranta A, Törrönen A, Uusitupa M. Impact of sugar beet pectin and polydextrose on fasting and postprandial glycemia and fasting concentrations of serum total and lipoprotein lipids in middle-aged subjects with abnormal glucose metabolism. Eur J Clin Nutr. 2006 Sep;60(9):1073-80. Epub 2006 Mar 8. — View Citation

Assessing a Polydextrose Containing Soup on Food Intake, Appetite and Biomarkers of Satiation and Satiety

Clinical Trial Details — Status: Terminated

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

References & Publications (4)

Outcome