Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 12:23 PM
Study NCT ID:
NCT02064205
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Appetite Suppression Trial With Polydextrose
Sponsor:
W.J. Pasman
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WM-01-2014 | OTHER | QPS, The Netherlands | View |