An interventional study of 12.5 g polydextrose and glucose syrup in Body Weight and Non-restrained Eaters, sponsored by W.J. Pasman. Completed at 1 site in Netherlands. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by W.J. Pasman · Not applicable, Interventional, and Health services research
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.
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:
Therefore, it is hypothesized that with the consumption of 12.5 g polydextrose as compared with the placebo, appetite will be suppressed, resulting in:
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 32 is below the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →W.J. Pasman is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Breakfast with pre-load four hours before lunch
Dietary Supplement: 12.5 g polydextrose · Dietary Supplement: glucose syrup
Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch.
Dietary Supplement: 12.5 g polydextrose · Dietary Supplement: glucose syrup
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.
Also known as: Litesse®Ultra TM
Glucose syrup is used a control product for the polydextrose
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.
Time frame: Four hours or 1.5 hour after consumption of a pre-load at up to day 22
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)
Time frame: 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.
Time frame: Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.
Recruitment lasted from May 2014 - August 2014. 121 subjects were planned for screening. 46 subjects met the inclusion criteria, 37 subjects did not show up, and 38 subjects had screening failures. The CRO that conducted the clinical trial was: QPS Netherlands B.V. Groningen The Netherlands
| Milestone | All Study Participants |
|---|---|
| Started | 32 |
| Condition a | 32 |
| Condition b | 32 |
| Condition c | 31 |
| Condition d | 32 |
| Completed | 31 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| kJ | Polydextrose Syrup at Breakfast [A] | Glucose Syrup at Breakfast (Control) [B] | Pre-load With Polydextroseglucose Before Lunch [C] | Pre-load With Yogurt and Glucose Before Lunch [D] |
|---|---|---|---|---|
| Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. | 2694 ± 1028 | 2537 ± 933 | 2317 ± 940 | 2335 ± 1051 |
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)
| mm*min | Polydextrose Syrup Preload With Yogurt With Breakfast [A] | Glucose Syrup as Proload With Breakfast (Control) [B] | Pre-load With Polydextrose Before Lunch [C] | Pre-load With Glucose Syrup Before Lunch [D] |
|---|---|---|---|---|
| Hunger score | 358.3 ± 183.4 | 336.8 ± 158.9 | 356.7 ± 169.1 | 280.2 ± 167.2 |
| Fullness score during first phase | -424.7 ± 192.4 | -443.0 ± 190.7 | -326.6 ± 207.6 | -308.2 ± 155.6 |
| Hunger score (satiety period) | 4898.9 ± 3424 | 4134.9 ± 2962.9 | 962.8 ± 1232.2 | 592.9 ± 987.2 |
| Fulness score (satiety period) | -6009.9 ± 3670.8 | -5048.3 ± 4088.4 | -734.8 ± 1263.5 | -1077.4 ± 1118.1 |
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.
| (mcg*min)/mL | Polydextrose Syrup at Breakfast [A] | Glucose Syrup at Breakfast (Control) [B] |
|---|---|---|
| CCK (AUC) | 241.15 ± 113.69 | 265.03 ± 112.44 |
| Ghrelin (AUC) | -23479 ± 33428 | -20902 ± 21150 |
| PYY (AUC) | 1745.5 ± 2861.7 | 1210.5 ± 2832.6 |
| GLP-1 (AUC) | 447.65 ± 298.11 | 316.02 ± 244.98 |
Collected over During the conduct of the study; June - November 2014. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Condition A | — | 0/32 (0%) | 5/32 (15.6%) |
| Condition B | — | 0/32 (0%) | 5/32 (15.6%) |
| Condition C | — | 0/31 (0%) | 2/31 (6.5%) |
| Condition D | — | 0/32 (0%) | 2/32 (6.3%) |
| Event | Condition A | Condition B | Condition C | Condition D |
|---|---|---|---|---|
| HeadacheNervous system disorders | 2/32 | 0/32 | 2/31 | 1/32 |
| NauseaGastrointestinal disorders | 2/32 | 0/32 | 1/31 | 1/32 |
| Abdominal painGastrointestinal disorders | 1/32 | 2/32 | 0/31 | 0/32 |
| VomittingGastrointestinal disorders | 0/32 | 0/32 | 1/31 | 0/32 |
| Infections and infestationsInfections and infestations | 0/32 | 1/32 | 1/31 | 0/32 |
| Abdominal distensionGastrointestinal disorders | 1/32 | 1/32 | 0/31 | 0/32 |
| DyspepsiaGastrointestinal disorders | 0/32 | 1/32 | 0/31 | 0/32 |
| Presyncope (light headedness)Nervous system disorders | 1/32 | 0/32 | 0/31 | 1/32 |
| DizzinessNervous system disorders | 1/32 | 1/32 | 0/31 | 0/32 |
| catheter site painGeneral disorders | 0/32 | 1/32 | 0/31 | 0/32 |
| Age, Categorical(Participants) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 32 |
| >=65 years | 0 |
| Age, Continuous(years) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Mean | 27.4 ± 6.6 |
| Sex: Female, Male(Participants) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Female | 32 |
| Male | 0 |
| Region of Enrollment(participants) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Netherlands | 32 |
| Body weight(kg) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Mean | 74.4 ± 7.8 |
| Height(meter) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Mean | 1.70 ± 0.04 |
| BMI(kg/m^2) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Mean | 25.9 ± 2.7 |
| BPsys(mm Hg) | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Mean | 113.5 ± 9.9 |
3 further baseline measures are reported on the registry.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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W.J. Pasman