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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01708681
Other study ID # NIFES-001
Secondary ID 2012/1084/REK ve
Status Completed
Phase N/A
First received October 11, 2012
Last updated October 5, 2015
Start date October 2012
Est. completion date September 2015

Study information

Verified date October 2015
Source National Institute of Nutrition and Seafood Research, Norway
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical Trial Summary

Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will:

1. affect the postprandial metabolism acutely (test-meal at beginning of the study)

2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)

3. affect gut microbiota composition


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 2015
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years of age

- Caucasian

Exclusion Criteria:

- Smoking

- Diabetes

- Hysterectomy

- Abnormal bleeding last 6 months

- Use of medication that affects lipid and glucose metabolism

- Large (>10%) alteration in body-weight the last 6 months

- Chronic, metabolic or acute disease or major surgery within last 3 months

- Dietary incompatibility with calcium supplementation and/ or seafood consumption (allergy, intolerance, dislike)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Lean seafood

Meat, egg, milk


Locations

Country Name City State
Norway National Institute of Nutrition and Seafood Research Bergen

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Nutrition and Seafood Research, Norway The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Postprandial metabolomic measurement Change from baseline at 4 weeks No
Other Gut microbiota composition Change from baseline at 4 weeks No
Primary Postprandial lipid measurement Change from baseline at 4 weeks No
Secondary Postprandial glucose measurement Change from baseline at 4 weeks No
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