Trial | NCT01101633  Report issue

Title

The Effect of Sodium Alginate on Appetite Sensation
The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sodium alginate ...

  • Study Participants

    20
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.
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.
Study Started
Feb 28
2009
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Last Update
Apr 12
2010
Estimate

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

1 Active Comparator

500 ml beverage containing alginate (3%)

2 Active Comparator

330 ml beverage containing alginate (3%)

3 Placebo Comparator

500 ml beverage without alginate (placebo)

4 Placebo Comparator

330 ml beverage without alginate (placebo)

Criteria 

Inclusion Criteria:

Healthy men and women
Normal to slight overweight (BMI: 22-28 kg/m2)
20-45 years of age

Exclusion Criteria:

Smoking
Daily medicine use (oral contraceptives excluded)
Use of dietary supplements
Blood donation 3 months prior to the study
Hb<7.5 mmol/l
Chronic illnesses such as hyperlipidemia, diabetes and inflammatory diseases
Pregnancy or breastfeeding
Elite athletes (>10 hours hard exercise/week)
Vegetarians
No Results Posted