The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)
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ClinicalTrials.gov Identifier: NCT01101633 |
Recruitment Status :
Completed
First Posted : April 12, 2010
Last Update Posted : April 12, 2010
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Condition or disease | Intervention/treatment | Phase |
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Obesity Overweight | Dietary Supplement: Alginate Dietary Supplement: Placebo | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | October 2009 |
Arm | Intervention/treatment |
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Active Comparator: 1
500 ml beverage containing alginate (3%)
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Dietary Supplement: Alginate
a 500 ml alginate beverage per meal test |
Active Comparator: 2
330 ml beverage containing alginate (3%)
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Dietary Supplement: Alginate
a 330 ml alginate beverage per meal test |
Placebo Comparator: 3
500 ml beverage without alginate (placebo)
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Dietary Supplement: Placebo
a 500 ml placebo beverage per meal test |
Placebo Comparator: 4
330 ml beverage without alginate (placebo)
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Dietary Supplement: Placebo
a 330 ml placebo beverage per meal test |
- appetite sensation [ Time Frame: 5 hours ]
- Plasma insulin and glucose level [ Time Frame: 5 hours ]
- Well being and adverse events [ Time Frame: 5 hours ]
- gastric emptying [ Time Frame: 5 hours ]
- spontaneous calorie intake [ Time Frame: 5 hours ]

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101633
Denmark | |
Department of Human Nutrtion, University of Copenhagen | |
Frederiksberg, Copenhagen, Denmark, 1958 |
Principal Investigator: | Arne Astrup, Dr. Med | University of Copenhagen |
Responsible Party: | Arne Astrup, Prof. Dr. Med., Department of Human Nutrition |
ClinicalTrials.gov Identifier: | NCT01101633 |
Other Study ID Numbers: |
H-C-2008-088 |
First Posted: | April 12, 2010 Key Record Dates |
Last Update Posted: | April 12, 2010 |
Last Verified: | August 2009 |
Appetite Energy intake gastric emptying well being Body weight |
Overweight Body Weight |