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Completed

NCT Number: NCT01101633

The Effect of Sodium Alginate on Appetite Sensation

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Human Nutrtion, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alginate

Dietary Supplement

a 500 ml alginate beverage per meal test

Placebo

Dietary Supplement

a 500 ml placebo beverage per meal test

Primary outcomes

  1. appetite sensation

    Time frame: 5 hours

Secondary outcomes

  1. Plasma insulin and glucose level

    Time frame: 5 hours

  2. Well being and adverse events

    Time frame: 5 hours

  3. gastric emptying

    Time frame: 5 hours

  4. spontaneous calorie intake

    Time frame: 5 hours

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • SBiotek

Registry information

Official study title

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

Acronym: B247Algobes

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 12, 2010
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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