Body WeightNCT02064205
Appetite Suppression Trial With Polydextrose
A study testing 12.5 g polydextrose and glucose syrup in people with Body Weight and Non-restrained Eaters, run by W.J. Pasman at 1 site in Netherlands.
Trial summary
Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Non-restrained Eaters
- What is being tested?
- 12.5 g polydextrose and glucose syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, female participants aged 20-45 years inclusive
- BMI: 20-30 kg/m2 inclusive
- Written consent regarding participation after full information regarding all details of the study
- Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)
Who cannot join
- Pregnancy
- On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product
- Reported postmenopausal
- Having menstruation problems, e.g. PCOS
- Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.)
- Aversion towards products (yoghurt) provided in the study
Show all 18Show fewer
- On-going use of any slimming preparations
- Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis
- Restrained eaters (score DEBQ >3.4)
- Participants consuming more than 23g of dietary fiber per day - P75 according to the Dutch National Food Consumption Survey - (as assessed with a general short questionnaire which gives estimation on the fiber intake. Exact fiber intake will not be calculated)
- Smoker in the last 3 months
- Heavy coffee drinkers (more than 6 cups a day)
- High level of physical activity: Participants who perform more than 3 hours of intense training/sport activity per week (this will not include normal cycling transport)
- Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink).
- Remark:
- When enough subjects are eligible (> 32), the women with the highest BMI will be selected to participate. At least 50% of the subjects will have a BMI ranging of 25-30. Also at least 50% of the women will be in the age range of 25-45 years. When more than 32 subjects are eligible the eldest subjects will be included.
- With respect to eligibility of the subjects:
- the BMI criterion always comes for age criterion, meaning that overweight is stressed to be of more importance for this study than age. Overweight will always come first, even when already > 50% of the women with a BMI 25-30 have been included. In this way the overweight group of women will be studied as much as possible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo Controlled, Randomized, Cross-over Study to Assess the Effects of Polydextrose on Appetite Suppression and Its Mechanisms of Action in Healthy Women With a Normal Weight and Overweight Female Participants.
Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Suppression of appetite may reduce energy intake, which in return may lead to body weight reduction. This study aims to verify the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight and overweight women.
Read the detailed description
Polydextrose is a well-tolerated, low calorie glucose polymer (4kJ/g) that can be easily incorporated into various food applications to replace sugar and fat (Auerbach et al., 2007). Polydextrose is poorly digested in the upper gastrointestinal tract and therefore shows fiber-like properties. The addition of polydextrose to foods may increase the satiating properties of foods.
Previous studies have shown that:
- Consuming polydextrose-containing preloads (6.25 - 25.0 g polydextrose) resulted in a significant lower energy intake at lunch compared to the control (Astbury et al., 2013; Ranawana et al., 2013; Hull et al., 2012; King et al., 2005).
- Polydextrose is able to modify appetite ratings at low (6.25 - 12.5 g polydextrose) (Hull et al., 2012) and high doses (56.7 g/d) (Konings et al., 2013).
- Polydextrose (15.0 g) induced enhanced GLP-1 response after a high-fat meal in obese participants (Tiihonen et al., 2012).
Therefore, it is hypothesized that with the consumption of 12.5 g polydextrose as compared with the placebo, appetite will be suppressed, resulting in:
- a lower consumption at lunch (energy intake at lunch)
- change in appetite scores (VAS)
- change in satiety hormones (CCK, PYY, GLP-1, ghrelin)
- change in glucose and insulin
- change in stomach emptying rate
- change in gastric wellbeing
- Conditions
- Body Weight, Non-restrained Eaters
- Being tested
- 12.5 g polydextrose, glucose syrup
- Keywords
- pre-load, satiety, energy intake, appetite
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12.5 g polydextroseDietary supplement
Also called Litesse®Ultra TM
Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.
glucose syrupDietary supplement
Glucose syrup is used a control product for the polydextrose
| Study group | Role | What they receive |
|---|---|---|
| polydextrose or glucose syrup at breakfast | Active comparator | Breakfast with pre-load four hours before lunch Receives: Dietary Supplement: 12.5 g polydextrose; Dietary Supplement: glucose syrup |
| Pre-load with yogurt and polydextrose or glucose later | Placebo comparator | Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch. Receives: Dietary Supplement: 12.5 g polydextrose; Dietary Supplement: glucose syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.
Measured: Four hours or 1.5 hour after consumption of a pre-load at up to day 22
Secondary outcomes (2)
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)
Measured: one day
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.
The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).
Area under the curves were calculated of the time curves.
Measured: Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Breakfast meal with or without polydextrose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.J. Pasman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, W.J. Pasman, TNO
- Investigators
- Naguib Muhsen, MD, Principal investigator, QPS, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064205
- Sponsor's protocol ID
- JZ PDX Satiety
- Other IDs
- WM-01-2014
- Status last verified
- May 2022
- First submitted
- 11 Feb 2014
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ibarra A, Olli K, Pasman W, Hendriks H, Alhoniemi E, Raza GS, Herzig KH, Tiihonen K. Effects of polydextrose with breakfast or with a midmorning preload on food intake and other appetite-related parameters in healthy normal-weight and overweight females: An acute, randomized, double-blind, placebo-controlled, and crossover study. Appetite. 2017 Mar 1;110:15-24. doi: 10.1016/j.appet.2016.12.002. Epub 2016 Dec 2.
PubMed 27916475
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Randomized, Cross-over Study to Assess the Effects of Polydextrose on Appetite Suppression and Its Mechanisms of Action in Healthy Women With a Normal Weight and Overweight Female Participants.
- ClinicalTrials.gov ID
- NCT02064205
- Acronym / sponsor ID
- JZ PDX Satiety
- Conditions
- Body Weight, Non-restrained Eaters
- Keywords
- pre-load, satiety, energy intake, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- W.J. PasmanUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 27 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Suppression of appetite may reduce energy intake, which in return may lead to body weight reduction. This study aims to verify the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight and overweight women.
Detailed description
Polydextrose is a well-tolerated, low calorie glucose polymer (4kJ/g) that can be easily incorporated into various food applications to replace sugar and fat (Auerbach et al., 2007). Polydextrose is poorly digested in the upper gastrointestinal tract and therefore shows fiber-like properties. The addition of polydextrose to foods may increase the satiating properties of foods.
Previous studies have shown that:
- Consuming polydextrose-containing preloads (6.25 - 25.0 g polydextrose) resulted in a significant lower energy intake at lunch compared to the control (Astbury et al., 2013; Ranawana et al., 2013; Hull et al., 2012; King et al., 2005).
- Polydextrose is able to modify appetite ratings at low (6.25 - 12.5 g polydextrose) (Hull et al., 2012) and high doses (56.7 g/d) (Konings et al., 2013).
- Polydextrose (15.0 g) induced enhanced GLP-1 response after a high-fat meal in obese participants (Tiihonen et al., 2012).
Therefore, it is hypothesized that with the consumption of 12.5 g polydextrose as compared with the placebo, appetite will be suppressed, resulting in:
- a lower consumption at lunch (energy intake at lunch)
- change in appetite scores (VAS)
- change in satiety hormones (CCK, PYY, GLP-1, ghrelin)
- change in glucose and insulin
- change in stomach emptying rate
- change in gastric wellbeing
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Breakfast meal with or without polydextrose
| Arm | Type | Receives |
|---|---|---|
| polydextrose or glucose syrup at breakfast | Active comparator | Dietary Supplement: 12.5 g polydextrose, Dietary Supplement: glucose syrupBreakfast with pre-load four hours before lunch |
| Pre-load with yogurt and polydextrose or glucose later | Placebo comparator | Dietary Supplement: 12.5 g polydextrose, Dietary Supplement: glucose syrupBreakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, female participants aged 20-45 years inclusive
- BMI: 20-30 kg/m2 inclusive
- Written consent regarding participation after full information regarding all details of the study
- Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)
Key exclusion criteria (18 listed)
- Pregnancy
- On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product
- Reported postmenopausal
- Having menstruation problems, e.g. PCOS
- Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.)
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 |
|---|---|---|
| 12.5 g polydextroseAlso: Litesse®Ultra TMAppetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect. | Dietary supplement | Pre-load with yogurt and polydextrose or glucose later, polydextrose or glucose syrup at breakfast |
| glucose syrupGlucose syrup is used a control product for the polydextrose | Dietary supplement | Pre-load with yogurt and polydextrose or glucose later, polydextrose or glucose syrup at breakfast |
Primary outcome
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
Time frame: Four hours or 1.5 hour after consumption of a pre-load at up to day 22
Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.
2 secondary outcomes
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
Time frame: one day
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
Time frame: Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27916475Ibarra A, Olli K, Pasman W, Hendriks H, Alhoniemi E, Raza GS, Herzig KH, Tiihonen K. Effects of polydextrose with breakfast or with a midmorning preload on food intake and other appetite-related parameters in healthy normal-weight and overweight females: An acute, randomized, double-blind, placebo-controlled, and crossover study. Appetite. 2017 Mar 1;110:15-24. doi: 10.1016/j.appet.2016.12.002. Epub 2016 Dec 2.
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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.
Naguib Muhsen, MD principal investigator
QPS, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12.5 g polydextrose and glucose syrup in people with Body Weight and Non-restrained Eaters, run by W.J. Pasman at 1 site in Netherlands.
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 4 inclusion and 18 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: finished, as of the sponsor's last update on 6 Jun 2022. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. (time frame: Four hours or 1.5 hour after consumption of a pre-load at up to day 22). 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 NCT02064205, which also lists 1 linked publication.
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 6 Jun 2022.