Clinical trial NCT01708681: Lean Seafood Intake and Postprandial Metabolism
Official title: Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Nutritional and Metabolic Diseases
Nutrition Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Keywords: Seafood
Meat
Egg
Milk
Postprandial lipid metabolism
Postprandial glucose metabolism
Triglycerides
Cholesterol
Postprandial incretins
Postprandial hormones
Lead sponsor: National Institute of Nutrition and Seafood Research, Norway
Sponsor class: OTHER_GOV
Collaborators: name: The Research Council of Norway
First posted: 2012-10-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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)

Primary outcomes:
measure: Postprandial lipid measurement
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Postprandial glucose measurement
timeFrame: Change from baseline at 4 weeks
Other outcomes:
measure: Postprandial metabolomic measurement
timeFrame: Change from baseline at 4 weeks
measure: Gut microbiota composition
timeFrame: Change from baseline at 4 weeks
Locations:
city: Bergen
country: Norway
facility: National Institute of Nutrition and Seafood Research
Study officials:
affiliation: NIFES
name: Bjørn Liaset, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aadland EK, Graff IE, Lavigne C, Eng O, Paquette M, Holthe A, Mellgren G, Madsen L, Jacques H, Liaset B. Lean Seafood Intake Reduces Postprandial C-peptide and Lactate Concentrations in Healthy Adults in a Randomized Controlled Trial with a Crossover Design. J Nutr. 2016 May;146(5):1027-34. doi: 10.3945/jn.115.229278. Epub 2016 Apr 20.
citation: Aadland EK, Lavigne C, Graff IE, Eng O, Paquette M, Holthe A, Mellgren G, Jacques H, Liaset B. Lean-seafood intake reduces cardiovascular lipid risk factors in healthy subjects: results from a randomized controlled trial with a crossover design. Am J Clin Nutr. 2015 Sep;102(3):582-92. doi: 10.3945/ajcn.115.112086. Epub 2015 Jul 29.