Body Weight, Non-restrained Eaters
Conditions
Keywords
pre-load, satiety, energy intake, appetite
Brief 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. 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
Interventions
DIETARY_SUPPLEMENT12.5 g polydextrose
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.
DIETARY_SUPPLEMENTglucose syrup
Glucose syrup is used a control product for the polydextrose
Sponsors
W.J. Pasman
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Breakfast meal with or without polydextrose
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, female participants aged 20-45 years inclusive 2. BMI: 20-30 kg/m2 inclusive 3. Written consent regarding participation after full information regarding all details of the study 4. Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)
Exclusion criteria
1. Pregnancy 2. 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 3. Reported postmenopausal 4. Having menstruation problems, e.g. PCOS 5. Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.) 6. Aversion towards products (yoghurt) provided in the study 7. On-going use of any slimming preparations 8. Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis 9. Restrained eaters (score DEBQ \>3.4) 10. 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) 11. Smoker in the last 3 months 12. Heavy coffee drinkers (more than 6 cups a day) 13. 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) 14. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | one day | 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) |
| Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22. | 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. |
Countries
Netherlands
Participant flow
Recruitment details
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
Pre-assignment details
In the study four test days were conducted, one weekly. Between test day there are six days of wash-out.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Baseline Charactistics of 32 Slightly Overweight Women |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 27.4 years STANDARD_DEVIATION 6.6 |
| BMI | 25.9 kg/m^2 STANDARD_DEVIATION 2.7 |
| Body weight | 74.4 kg STANDARD_DEVIATION 7.8 |
| BPdia | 64.2 mm Hg STANDARD_DEVIATION 9 |
| BPsys | 113.5 mm Hg STANDARD_DEVIATION 9.9 |
| Dietary fiber intake | 18 grams/day STANDARD_DEVIATION 4 |
| Dutch Eating Restraintness Score | 2.4 units on a scale STANDARD_DEVIATION 0.4 |
| Height | 1.70 meter STANDARD_DEVIATION 0.04 |
| Region of Enrollment Netherlands | 32 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 32 | 5 / 32 | 2 / 31 | 2 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 31 | 0 / 32 |
Outcome results
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.
Time frame: Four hours or 1.5 hour after consumption of a pre-load at up to day 22
Population: Energy intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polydextrose Syrup at Breakfast [A] | Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. | 2694 kJ | Standard Deviation 1028 |
| Glucose Syrup at Breakfast (Control) [B] | Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. | 2537 kJ | Standard Deviation 933 |
| Pre-load With Polydextroseglucose Before Lunch [C] | Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. | 2317 kJ | Standard Deviation 940 |
| 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. | 2335 kJ | Standard Deviation 1051 |
Comparison: A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)p-value: 0.2918Mixed Models Analysis
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.
Time frame: Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.
Population: Only in condition A and B blood was drawn and satiety hormones were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polydextrose Syrup at Breakfast [A] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | CCK (AUC) | 241.15 (mcg*min)/mL | Standard Deviation 113.69 |
| Polydextrose Syrup at Breakfast [A] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | Ghrelin (AUC) | -23479 (mcg*min)/mL | Standard Deviation 33428 |
| Polydextrose Syrup at Breakfast [A] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | PYY (AUC) | 1745.5 (mcg*min)/mL | Standard Deviation 2861.7 |
| Polydextrose Syrup at Breakfast [A] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | GLP-1 (AUC) | 447.65 (mcg*min)/mL | Standard Deviation 298.11 |
| Glucose Syrup at Breakfast (Control) [B] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | GLP-1 (AUC) | 316.02 (mcg*min)/mL | Standard Deviation 244.98 |
| Glucose Syrup at Breakfast (Control) [B] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | CCK (AUC) | 265.03 (mcg*min)/mL | Standard Deviation 112.44 |
| Glucose Syrup at Breakfast (Control) [B] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | PYY (AUC) | 1210.5 (mcg*min)/mL | Standard Deviation 2832.6 |
| Glucose Syrup at Breakfast (Control) [B] | Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | Ghrelin (AUC) | -20902 (mcg*min)/mL | Standard Deviation 21150 |
Comparison: A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.p-value: 0.0216Mixed Models Analysis
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)
Time frame: one day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polydextrose Syrup at Breakfast [A] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score | 358.3 mm*min | Standard Deviation 183.4 |
| Polydextrose Syrup at Breakfast [A] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fullness score during first phase | -424.7 mm*min | Standard Deviation 192.4 |
| Polydextrose Syrup at Breakfast [A] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score (satiety period) | 4898.9 mm*min | Standard Deviation 3424 |
| Polydextrose Syrup at Breakfast [A] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fulness score (satiety period) | -6009.9 mm*min | Standard Deviation 3670.8 |
| Glucose Syrup at Breakfast (Control) [B] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fullness score during first phase | -443.0 mm*min | Standard Deviation 190.7 |
| Glucose Syrup at Breakfast (Control) [B] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score (satiety period) | 4134.9 mm*min | Standard Deviation 2962.9 |
| Glucose Syrup at Breakfast (Control) [B] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fulness score (satiety period) | -5048.3 mm*min | Standard Deviation 4088.4 |
| Glucose Syrup at Breakfast (Control) [B] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score | 336.8 mm*min | Standard Deviation 158.9 |
| Pre-load With Polydextroseglucose Before Lunch [C] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score (satiety period) | 962.8 mm*min | Standard Deviation 1232.2 |
| Pre-load With Polydextroseglucose Before Lunch [C] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fullness score during first phase | -326.6 mm*min | Standard Deviation 207.6 |
| Pre-load With Polydextroseglucose Before Lunch [C] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fulness score (satiety period) | -734.8 mm*min | Standard Deviation 1263.5 |
| Pre-load With Polydextroseglucose Before Lunch [C] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score | 356.7 mm*min | Standard Deviation 169.1 |
| Pre-load With Yogurt and Glucose Before Lunch [D] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fulness score (satiety period) | -1077.4 mm*min | Standard Deviation 1118.1 |
| Pre-load With Yogurt and Glucose Before Lunch [D] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Fullness score during first phase | -308.2 mm*min | Standard Deviation 155.6 |
| Pre-load With Yogurt and Glucose Before Lunch [D] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score | 280.2 mm*min | Standard Deviation 167.2 |
| Pre-load With Yogurt and Glucose Before Lunch [D] | The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | Hunger score (satiety period) | 592.9 mm*min | Standard Deviation 987.2 |
Comparison: AUC of hunger scores before preload intake for condition C versus D.p-value: 0.0109Mixed Models Analysis