Satiation, SatietyNCT02258750
Assessing a Polydextrose Containing Soup on Food Intake, Appetite and Biomarkers of Satiation and Satiety
A study testing Polydextrose in people with Satiation, Satiety, run by University of Liverpool at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Satiation, Satiety
- What is being tested?
- Polydextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Official title: Experimental Study to Investigate the Effect of a High Fibre, Polydextrose-enriched Tomato Soup on Food Intake, the Experience of Appetite and Biomarkers of Satiation and Satiety
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.
Read the detailed 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.
- Conditions
- Satiation, Satiety
- Being tested
- Polydextrose, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Polydextrose | Experimental | Tomato soup enriched with added polydextrose Receives: Dietary Supplement: Polydextrose |
| Control | Placebo comparator | Tomato soup without added polydextrose Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 180 minutes
Secondary outcomes (2)
Changes in subjective experience of satiation after ingestion of high fibre polydextrose enriched tomato soup compared to control
Visual Analogue Scale questionnaires (for appetite) completed before and after the soup and ad-libitum main meals. Questionnaire responses will be compared pre- and post-intervention across the 3 time points (Baseline day, Day 1 and final dosing day)
Measured: 30 minutes
Changes in subjective experience of appetite and palatability in polydextrose tomato soup compared to control
Visual Analogue Scale questionnaires (for appetite and palatability taken before and after each meal (breakfast, soup, lunch, dinner) and at hourly intervals throughout the day. Questionnaire responses will be compared pre- and post-intervention across the 3 time points (Baseline day, Day 1 and final dosing day)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: End of EU funding for the work package under investigation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Satiation, SatietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Una Masic, University of Liverpool
- Investigators
- Joanne A Harrold, Doctor, Principal investigator, University of LiverpoolJason CG Halford, Professor, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258750
- Sponsor's protocol ID
- ULKLSA002
- Status last verified
- Jan 2016
- First submitted
- 25 Sep 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15234083King 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.
PubMed 16022761Ranawana 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.
PubMed 22717960Schwab 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.
PubMed 16523204
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study to Investigate the Effect of a High Fibre, Polydextrose-enriched Tomato Soup on Food Intake, the Experience of Appetite and Biomarkers of Satiation and Satiety
- ClinicalTrials.gov ID
- NCT02258750
- Acronym / sponsor ID
- ULKLSA002
- Conditions
- Satiation, Satiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of EU funding for the work package under investigation
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polydextrose | Experimental | Dietary Supplement: PolydextroseTomato soup enriched with added polydextrose |
| Control | Placebo comparator | Other: ControlTomato soup without added polydextrose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolydextroseHigh 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. | Dietary supplement | Polydextrose |
| ControlTomato 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. | Other | Control |
Primary outcome
Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake
Time frame: 90 minutes
Calorie intake at ad-libitum lunch, dinner, and evening snack pack intake
More stable blood glucose response immediately after and after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control
Time frame: 180 minutes
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)
Larger short chain fatty acid fermentation of carbohydrate after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control
Time frame: 180 minutes
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)
2 secondary outcomes
Changes in subjective experience of satiation after ingestion of high fibre polydextrose enriched tomato soup compared to control
Time frame: 30 minutes
Changes in subjective experience of appetite and palatability in polydextrose tomato soup compared to control
Time frame: 60 minutes
Results and safety
The study was stopped early (reason given: End of EU funding for the work package under investigation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Background: PubMed 15234083Flood 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.
- Background: PubMed 16022761King 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.
- Background: PubMed 22717960Ranawana 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.
- Background: PubMed 16523204Schwab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne A Harrold, Doctor principal investigator
University of Liverpool
Jason CG Halford, Professor principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose in people with Satiation, Satiety, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of EU funding for the work package under investigation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake (time frame: 90 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258750, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.