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| ID | Type | Description | Link |
|---|---|---|---|
| WM-01-2014 | Other Identifier | QPS, The Netherlands |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polydextrose or glucose syrup at breakfast | Active Comparator | Breakfast with pre-load four hours before lunch |
|
| Pre-load with yogurt and polydextrose or glucose later | Placebo Comparator | Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12.5 g polydextrose | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Four hours or 1.5 hour after consumption of a pre-load at up to day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Naguib Muhsen, MD | QPS, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS | Groningen | 9713AG | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27916475 | Derived | 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. |
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In the study four test days were conducted, one weekly. Between test day there are six days of wash-out.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min Eight orders: A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Charactistics of 32 Slightly Overweight Women | Baseline data of the subjects were measured at screening at least one week before the start of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Energy intake | Posted | Mean | Standard Deviation | kJ | Four hours or 1.5 hour after consumption of a pre-load at up to day 22 |
|
During the conduct of the study; June - November 2014
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Condition A | Breakfast with preload of yogurt and polydextrose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| W.J. Pasman, PhD | TNO | +31888665129 | wilrike.pasman@tno.nl |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C033375 | polydextrose |
| D066248 | High Fructose Corn Syrup |
| ID | Term |
|---|---|
| D000073417 | Dietary Sugars |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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Breakfast meal with or without polydextrose
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|
| glucose syrup | Dietary Supplement | Glucose syrup is used a control product for the polydextrose |
|
| 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. | Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | meter |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| BPsys | Systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| BPdia | Diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Dutch Eating Restraintness Score | Score ranges from 0 - 5 0 = unrestrained 5 = very restrained | Mean | Standard Deviation | units on a scale |
|
| Dietary fiber intake | Mean | Standard Deviation | grams/day |
|
Breakfast with control pre-load four hours before lunch Yogurt with control (glucose syrup) is tested for its satiating effect. glucose syrup: Glucose syrup is used a control product for the polydextrose |
| OG002 | Pre-load With Polydextroseglucose Before Lunch [C] | Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch. 12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch. |
| OG003 | Pre-load With Yogurt and Glucose Before Lunch [D] | Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch. Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | mm*min | one day |
|
|
|
|
| Secondary | 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. | Only in condition A and B blood was drawn and satiety hormones were analyzed. | Posted | Mean | Standard Deviation | (mcg*min)/mL | Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22. |
|
|
|
|
| 0 |
| 32 |
| 5 |
| 32 |
| EG001 | Condition B | Breakfast with preload of yogurt and glucose control | 0 | 32 | 5 | 32 |
| EG002 | Condition C | Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose | 0 | 31 | 2 | 31 |
| EG003 | Condition D | Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup | 0 | 32 | 2 | 32 |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Presyncope (light headedness) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| catheter site pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pyrexia (fever) | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D064427 |
| Nutritive Sweeteners |
| D013549 | Sweetening Agents |
| D005421 | Flavoring Agents |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| Fullness score during first phase |
|
| Hunger score (satiety period) |
|
| Fulness score (satiety period) |
|
| PYY (AUC) |
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| GLP-1 (AUC) |
|