ObesityNCT01316016
Antidiabetic Properties of Rose Hip
A study testing Rose hip in people with Obesity, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Rose hip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2009to Jan 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30
- willingness to participate in the study
- willingness to comply with the daily intake of drinks and the recommended energy intake during the course of the study
Who cannot join
- diabetes
- previous or ongoing insulin treatment
- abnormal thyroid status
- abnormal liver status
- abnormal kidney status
- known gastrointestinal disorder
- pregnancy
- suspected allergy to ingredients of the drinks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rose Hip Intake on Risk Markers of Type 2 Diabetes and Cardiovascular Disease: a Randomized Double-blind Cross-over Investigation in Obese Persons
The purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease.
- Conditions
- Obesity
- Being tested
- Rose hip
- Keywords
- obesity, glucose intolerance, cholesterol, blood pressure
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rose hipDietary supplement
40 g of rose hip powder daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rose hip | Experimental | Not described Receives: Dietary Supplement: Rose hip |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionJan 2011
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 ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Investigators
- Per Katzman, MD/PhD, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316016
- Sponsor's protocol ID
- LUAFC002
- Status last verified
- Feb 2011
- First submitted
- 15 Mar 2011
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersson U, Henriksson E, Strom K, Alenfall J, Goransson O, Holm C. Rose hip exerts antidiabetic effects via a mechanism involving downregulation of the hepatic lipogenic program. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E111-21. doi: 10.1152/ajpendo.00268.2010. Epub 2010 Oct 19.
PubMed 20959531
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rose Hip Intake on Risk Markers of Type 2 Diabetes and Cardiovascular Disease: a Randomized Double-blind Cross-over Investigation in Obese Persons
- ClinicalTrials.gov ID
- NCT01316016
- Acronym / sponsor ID
- LUAFC002
- Conditions
- Obesity
- Keywords
- obesity, glucose intolerance, cholesterol, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Mar 2011 (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.
The purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rose hip | Experimental | Dietary Supplement: Rose hip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 30
- willingness to participate in the study
- willingness to comply with the daily intake of drinks and the recommended energy intake during the course of the study
Key exclusion criteria (8 listed)
- diabetes
- previous or ongoing insulin treatment
- abnormal thyroid status
- abnormal liver status
- abnormal kidney status
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 |
|---|---|---|
| Rose hip40 g of rose hip powder daily for 6 weeks. | Dietary supplement | Rose hip |
Primary outcome
Not reported in the source record.
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 Mar 2011.
- Background: PubMed 20959531Andersson U, Henriksson E, Strom K, Alenfall J, Goransson O, Holm C. Rose hip exerts antidiabetic effects via a mechanism involving downregulation of the hepatic lipogenic program. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E111-21. doi: 10.1152/ajpendo.00268.2010. Epub 2010 Oct 19.
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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.
Per Katzman, MD/PhD study chair
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rose hip in people with Obesity, run by Lund University 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 3 inclusion and 8 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 Mar 2011. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316016, 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 Mar 2011.