The Effect of Sodium Alginate on Appetite Sensation

Phase 1

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: Alginate; Dietary Supplement: Placebo

• Registration Number: NCT01101633
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-08
• Study First Submitted: 2009-08-25
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted QC: 2010-04-09
• Last Update Submitted: 2010-04-09
• Study First Posted: 2010-04-12
• Last Update Posted: 2010-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Alginate	500 ml beverage containing alginate (3%)
3	Placebo	500 ml beverage without alginate (placebo)
4	Placebo	330 ml beverage without alginate (placebo)
2	Alginate	330 ml beverage containing alginate (3%)

Primary Outcome Measures

Name	Time	Method
appetite sensation	5 hours

Secondary Outcome Measures

Name	Time	Method
Plasma insulin and glucose level	5 hours
Well being and adverse events	5 hours
spontaneous calorie intake	5 hours
gastric emptying	5 hours

Trial Locations

Locations (1)

Department of Human Nutrtion, University of Copenhagen; 🇩🇰 Frederiksberg, Copenhagen, Denmark