Healthy SubjectsNCT02227511
Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects
A study testing Fruits and Nuts in people with Healthy Subjects, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Fruits and Nuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
Who cannot join
- significant diseases that can affect outcomes, mental disorders that can affect participation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Subjects
- Being tested
- Fruits, Nuts
- Keywords
- fruit, nuts, liver fat, insulin, glucose, Focus of the study is to compare the often given advice to eat fruit, containing large amount of glucose and fructose, with nuts that are more rich in fat.
- Medical subject headings
- Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruitsDietary supplement
Randomization to extra fruit or nuts as snacks
NutsDietary supplement
Also called Randomization to extra fruit or nuts as snacks
| Study group | Role | What they receive |
|---|---|---|
| fruit | Active comparator | Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals Receives: Dietary Supplement: Fruits |
| nuts | Active comparator | Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals Receives: Dietary Supplement: Nuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of fat in the liver by magnetic resonance imaging
exact measurement of fat in the liver by liver spectroscopy
Measured: two months
Secondary outcomes (1)
cardiovascular risk factors
Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227511
- Sponsor's protocol ID
- 2014/170-31
- Status last verified
- May 2016
- First submitted
- 26 Aug 2014
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Agebratt C, Strom E, Romu T, Dahlqvist-Leinhard O, Borga M, Leandersson P, Nystrom FH. A Randomized Study of the Effects of Additional Fruit and Nuts Consumption on Hepatic Fat Content, Cardiovascular Risk Factors and Basal Metabolic Rate. PLoS One. 2016 Jan 20;11(1):e0147149. doi: 10.1371/journal.pone.0147149. eCollection 2016.
PubMed 26788923
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02227511
- Acronym / sponsor ID
- 2014/170-31
- Conditions
- Healthy Subjects
- Keywords
- fruit, nuts, liver fat, insulin, glucose, Focus of the study is to compare the often given advice to eat fruit, containing large amount of glucose and fructose, with nuts that are more rich in fat.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fruit | Active comparator | Dietary Supplement: FruitsParticipants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals |
| nuts | Active comparator | Dietary Supplement: NutsParticipants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (1 listed)
- significant diseases that can affect outcomes, mental disorders that can affect participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruitsRandomization to extra fruit or nuts as snacks | Dietary supplement | fruit |
| NutsAlso: Randomization to extra fruit or nuts as snacks | Dietary supplement | nuts |
Primary outcome
amount of fat in the liver by magnetic resonance imaging
Time frame: two months
exact measurement of fat in the liver by liver spectroscopy
1 secondary outcome
cardiovascular risk factors
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 26788923Agebratt C, Strom E, Romu T, Dahlqvist-Leinhard O, Borga M, Leandersson P, Nystrom FH. A Randomized Study of the Effects of Additional Fruit and Nuts Consumption on Hepatic Fat Content, Cardiovascular Risk Factors and Basal Metabolic Rate. PLoS One. 2016 Jan 20;11(1):e0147149. doi: 10.1371/journal.pone.0147149. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruits and Nuts in people with Healthy Subjects, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of fat in the liver by magnetic resonance imaging (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02227511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.