NCT01101633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
Last Updated

April 12, 2010

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

August 25, 2009

Last Update Submit

April 9, 2010

Conditions

ObesityOverweight

Keywords

AppetiteEnergy intakegastric emptyingwell beingBody weight

Outcome Measures

Primary Outcomes (1)

  • appetite sensation

    5 hours

Secondary Outcomes (4)

  • Plasma insulin and glucose level

    5 hours

  • Well being and adverse events

    5 hours

  • gastric emptying

    5 hours

  • spontaneous calorie intake

    5 hours

Study Arms (4)

1

ACTIVE COMPARATOR

500 ml beverage containing alginate (3%)

Dietary Supplement: Alginate

2

ACTIVE COMPARATOR

330 ml beverage containing alginate (3%)

Dietary Supplement: Alginate

3

PLACEBO COMPARATOR

500 ml beverage without alginate (placebo)

Dietary Supplement: Placebo

4

PLACEBO COMPARATOR

330 ml beverage without alginate (placebo)

Dietary Supplement: Placebo

Interventions

AlginateDIETARY_SUPPLEMENT

a 500 ml alginate beverage per meal test

1
PlaceboDIETARY_SUPPLEMENT

a 500 ml placebo beverage per meal test

3

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Normal to slight overweight (BMI: 22-28 kg/m2)
  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrtion, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

Location

Related Publications (1)

  • Georg Jensen M, Kristensen M, Belza A, Knudsen JC, Astrup A. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects. Obesity (Silver Spring). 2012 Sep;20(9):1851-8. doi: 10.1038/oby.2011.232. Epub 2011 Jul 21.

    PMID: 21779093DERIVED

MeSH Terms

Conditions

ObesityOverweightBody Weight

Interventions

Alginates

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Study Officials

  • Arne Astrup, Dr. Med

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

April 12, 2010

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 12, 2010

Record last verified: 2009-08

Locations

DK(1)