Trials / Completed
CompletedNCT01101633
The Effect of Sodium Alginate on Appetite Sensation
The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.
Detailed description
The project consists of two different studies: Study I: A randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. Here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. Subjective appetite sensation will be measured with Visual Analogue Scale (VAS) every 30 minutes four up to 5 hours. An additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered. Study II: Secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. A total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. The development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of CVD and type 2 diabetes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Alginate | a 500 ml alginate beverage per meal test |
| DIETARY_SUPPLEMENT | Alginate | a 330 ml alginate beverage per meal test |
| DIETARY_SUPPLEMENT | Placebo | a 500 ml placebo beverage per meal test |
| DIETARY_SUPPLEMENT | Placebo | a 330 ml placebo beverage per meal test |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2010-04-12
- Last updated
- 2010-04-12
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01101633. Inclusion in this directory is not an endorsement.