The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

University of Copenhagen

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Alginate

Study type: Interventional

Funder types: Other

Identifiers

NCT01101633

H-C-2008-088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

500 ml beverage containing alginate (3%)

Treatment:

Dietary Supplement: Alginate

Dietary Supplement: Alginate

2

Active Comparator group

Description:

330 ml beverage containing alginate (3%)

Treatment:

Dietary Supplement: Alginate

Dietary Supplement: Alginate

3

Placebo Comparator group

Description:

500 ml beverage without alginate (placebo)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Placebo

4

Placebo Comparator group

Description:

330 ml beverage without alginate (placebo)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Placebo