Healthy Subjects Clinical Trial
Official title:
Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects
Verified date | May 2016 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: University Hospital Linkoeping. |
Study type | Interventional |
Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic rate, liver steatosis and physical activity are investigated ahead of start of the study and at the end of the trial period och two months. Participants will be allowed to buy fruits or nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed for the costs of the snacks.
Status | Completed |
Enrollment | 27 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 76 Years |
Eligibility |
Inclusion Criteria: - healthy subjects Exclusion Criteria: - significant diseases that can affect outcomes, mental disorders that can affect participation. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Sweden | Fredrik H Nystrom | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | amount of fat in the liver by magnetic resonance imaging | exact measurement of fat in the liver by liver spectroscopy | two months | Yes |
Secondary | cardiovascular risk factors | Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples. | two months | Yes |
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