Lean Seafood Intake and Postprandial Metabolism

Glucose Metabolism Disorders Clinical Trial

— LeSIP  

Official title:

Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design

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

• Disease
• Glucose Metabolism Disorders
• Hyperlipidemias
• Metabolic Diseases
• Nutrition Disorders
• Nutritional and Metabolic Diseases

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

External Links

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