Clinical trial NCT01101633: The Effect of Sodium Alginate on Appetite Sensation
Official title: The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Overweight
Keywords: Appetite
Energy intake
gastric emptying
well being
Body weight
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: SBiotek
First posted: 2010-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: appetite sensation
timeFrame: 5 hours
Secondary outcomes:
measure: Plasma insulin and glucose level
timeFrame: 5 hours
measure: Well being and adverse events
timeFrame: 5 hours
measure: gastric emptying
timeFrame: 5 hours
measure: spontaneous calorie intake
timeFrame: 5 hours
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrtion, University of Copenhagen
state: Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Arne Astrup, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Georg Jensen M, Kristensen M, Belza A, Knudsen JC, Astrup A. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects. Obesity (Silver Spring). 2012 Sep;20(9):1851-8. doi: 10.1038/oby.2011.232. Epub 2011 Jul 21.