NCT01231178

Brief Summary

The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink supplement on development in body weight and body composition, and risk markers for type-2 diabetes and cardiovascular disease in obese subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable 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, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
Last Updated

November 1, 2010

Status Verified

April 1, 2010

Enrollment Period

5 months

First QC Date

April 8, 2010

Last Update Submit

October 29, 2010

Conditions

ObesityType 2 DiabetesCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Body weight

    12 Weeks

Secondary Outcomes (4)

  • Blood pressure

    12 weeks

  • Risk markers for type 2 diabetes

    12 weeks

  • Risk markers for cardiovascular disease

    12 Weeks

  • Body composition

    12 Weeks

Study Arms (2)

Alginate based beverage

ACTIVE COMPARATOR
Dietary Supplement: Alginate beverage

Control beverage

PLACEBO COMPARATOR
Dietary Supplement: Control beverage

Interventions

Alginate beverageDIETARY_SUPPLEMENT

The dosage is 3x500ml daily

Also known as: Protanal
Alginate based beverage
Control beverageDIETARY_SUPPLEMENT

The dosage is 3x500ml daily

Also known as: Maltodextrin
Control beverage

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Overweight to obese (BMI 28-45 kg/m2)

You may not qualify if:

  • Chronic diseases including:liver and kidney disease, including P-Alanine aminotransferase (ALT), P-aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatinine kinase and P-lactate dehydrogenase (LD)\> 2.0 times the upper limit of normal (ULN) (measured at the screening at the Department of Human Nutrition)
  • systemic infections and metabolic diseases that can interfere with energy balance,
  • diabetes or fasting blood glucose concentration\> 7.0 mM, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmHg, hyperlipidemia (total cholesterol\> 6.5 mM and triglycerides\> 5.0 mM) (measured by the screening at the Department of Human Nutrition)
  • Food allergies
  • Psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment
  • Use of dietary supplements (during the experimental period and 3 months before study start)
  • Provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin \<7.5 mmol / l (measured at the screening at the Department of Human Nutrition)
  • Smoking (throughout the trial and 6 months before study start)
  • Elite Athletes (\> 10 hours strenuous exercise per week, self-reported)
  • Women who are pregnant or breastfeeding, and post-menustruelle (self reported)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, Copenhagen, 1958, Denmark

Location

Related Publications (1)

  • Georg Jensen M, Kristensen M, Astrup A. Effect of alginate supplementation on weight loss in obese subjects completing a 12-wk energy-restricted diet: a randomized controlled trial. Am J Clin Nutr. 2012 Jul;96(1):5-13. doi: 10.3945/ajcn.111.025312. Epub 2012 May 30.

    PMID: 22648709DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Arne Astrup, Prof. MD.

    Department of Human Nutrtion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2010

First Posted

November 1, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 1, 2010

Record last verified: 2010-04

Locations

DK(1)