NCT02258750

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

September 25, 2014

Last Update Submit

January 6, 2016

Conditions

Satiation, Satiety

Outcome Measures

Primary Outcomes (3)

  • Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake

    Calorie intake at ad-libitum lunch, dinner, and evening snack pack intake

    90 minutes

  • More stable blood glucose response immediately after and after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control

    Finger prick blood glucose measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)

    180 minutes

  • Larger short chain fatty acid fermentation of carbohydrate after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control

    Hydrogen breath test measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)

    180 minutes

Secondary Outcomes (2)

  • Changes in subjective experience of satiation after ingestion of high fibre polydextrose enriched tomato soup compared to control

    30 minutes

  • Changes in subjective experience of appetite and palatability in polydextrose tomato soup compared to control

    60 minutes

Study Arms (2)

Polydextrose

EXPERIMENTAL

Tomato soup enriched with added polydextrose

Dietary Supplement: Polydextrose

Control

PLACEBO COMPARATOR

Tomato soup without added polydextrose

Other: Control

Interventions

PolydextroseDIETARY_SUPPLEMENT

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.

Polydextrose
ControlOTHER

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.

Control

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

Related 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. doi: 10.1016/j.fct.2004.04.015.

    PMID: 15234083BACKGROUND

  • 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. doi: 10.1079/bjn20051431.

    PMID: 16022761BACKGROUND

  • 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.

    PMID: 22717960BACKGROUND

  • Schwab U, Louheranta A, Torronen 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. doi: 10.1038/sj.ejcn.1602421. Epub 2006 Mar 8.

    PMID: 16523204BACKGROUND

MeSH Terms

Interventions

polydextrose

Study Officials

  • Joanne A Harrold, Doctor

    University of Liverpool

    PRINCIPAL INVESTIGATOR

  • Jason CG Halford, Professor

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Doctoral Associate

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 7, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

GB(1)