NCT00639041

Brief Summary

The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products cardiovascular risk factors in hypertriglyceridemic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
Last Updated

September 22, 2011

Status Verified

February 1, 2008

Enrollment Period

1.1 years

First QC Date

March 12, 2008

Last Update Submit

September 21, 2011

Conditions

Hypertriglyceridemia

Keywords

n-3 LC-PUFAhypertriglyceridemichumanTAG

Outcome Measures

Primary Outcomes (1)

  • blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)

    15 weeks

Secondary Outcomes (3)

  • blood pressure

    15 weeks

  • fibrinogen

    15 weeks

  • homocysteine

    15 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

n-3 LC-PUFA

ACTIVE COMPARATOR
Dietary Supplement: n-3 LC-PUFA

Interventions

n-3 LC-PUFADIETARY_SUPPLEMENT

n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d

n-3 LC-PUFA
PlaceboDIETARY_SUPPLEMENT

dairy products without special oils

placebo

Eligibility Criteria

Age43 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L

You may not qualify if:

  • blood diluted medications
  • lipid lowering medications
  • glucocorticoids
  • gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
  • daily alcohol abuse
  • taking dietary supplements (e. g., fish oil capsules, vitamin E)
  • known allergies or foodstuff indigestibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • Dawczynski C, Martin L, Wagner A, Jahreis G. n-3 LC-PUFA-enriched dairy products are able to reduce cardiovascular risk factors: a double-blind, cross-over study. Clin Nutr. 2010 Oct;29(5):592-9. doi: 10.1016/j.clnu.2010.02.008. Epub 2010 Mar 20.

    PMID: 20304540BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    University of Jena, Dept. of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

April 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 22, 2011

Record last verified: 2008-02

Locations

DE(1)