The Effect of Sodium Alginate on Appetite Sensation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: Alginate
* Dietary Supplement: Alginate
* Dietary Supplement: Placebo
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>500 ml beverage containing alginate (3%) | Dietary Supplement: Alginate<br>* a 500 ml alginate beverage per meal test<br>|
| Active Comparator: 2<br>330 ml beverage containing alginate (3%) | Dietary Supplement: Alginate<br>* a 330 ml alginate beverage per meal test<br>|
| Placebo Comparator: 3<br>500 ml beverage without alginate (placebo) | Dietary Supplement: Placebo<br>* a 500 ml placebo beverage per meal test<br>|
| Placebo Comparator: 4<br>330 ml beverage without alginate (placebo) | Dietary Supplement: Placebo<br>* a 330 ml placebo beverage per meal test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appetite sensation |  | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma insulin and glucose level |  | 5 hours | 
| Well being and adverse events |  | 5 hours | 
| gastric emptying |  | 5 hours | 
| spontaneous calorie intake |  | 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appetite, Energy intake, gastric emptying, well being, Body weight