ObesityNCT03102853
Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects
A study testing Nordic diet in people with Obesity and Cardiovascular Risk Factor, run by Lund University at 1 site in Sweden.
Trial summary
This project will examine whether long-term consumption of healthy Nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. Read more about this study
- Who is it for?
- Ages 25 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Risk Factor, Diet Modification
- What is being tested?
- Nordic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2016to 31 Dec 2019
- 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 25 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 25-67 years, BMI 30-40 kg/m2, waist circumference men >102cm and women > 88cm or sagittal abdominal diameter men >22cm and women >20cm, stable body weight
Who cannot join
- glucose >7.0 mmol/l, B-Hb1aC >48 mmol/L, triglycerides >4 mmol/l, total cholesterol >8 mmol/l, bloodpressure >160/100 mmHg, chronic disease, gastro-intestinal disease, hyper-/hypothyroidism, alcohol abuse, cancer, gastric bypass operation, gluten allergy, lactose intolerance, pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital
Lund, 221 00
About this study
Official title: Effects of a Healthy Nordic Diet on Abdominal Obesity, Body Weight Maintenance and Cardiometabolic Risk: a 2-year Randomised Controlled Study
This project will examine whether long-term consumption of healthy Nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. The study will be performed with the aim to achieve a substantial body weight loss in the first phase by prescribing a standardized low caloric dietary formula. The follow-up phase will be a body weight-maintenance period and the subjects will be randomised to a healthy Nordic diet group and a control diet group. During the study body weight will be monitored and other measurements will include insulin sensitivity, blood lipids and inflammation markers.
- Conditions
- Obesity, Cardiovascular Risk Factor, Diet Modification
- Being tested
- Nordic diet, Control diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic dietOther
Control dietOther
| Study group | Role | What they receive |
|---|---|---|
| Nordic diet | Active comparator | Not described Receives: Other: Nordic diet |
| Control diet | Other | Not described Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sagittal abdominal diameter
Measured: Change from baseline to month 6, 12, 18, 24
Change in body weight
Measured: Change from baseline to month 6, 12, 18, 24
Secondary outcomes (6)
Insulin sensitivity (HOMA-IR)
Measured: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Body fat and body lean mass (BIA)
Measured: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Blood lipids
Measured: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Blood pressure
Measured: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Markers of kidney and liver function
Measured: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Markers of inflammation and endothelial function
Measured: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start15 Aug 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital
- Responsible party
- Principal investigator, LieseLotte Cloetens, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102853
- Sponsor's protocol ID
- NOVI377
- Status last verified
- May 2020
- First submitted
- 22 Mar 2017
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Healthy Nordic Diet on Abdominal Obesity, Body Weight Maintenance and Cardiometabolic Risk: a 2-year Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03102853
- Acronym / sponsor ID
- NOVI377
- Conditions
- Obesity, Cardiovascular Risk Factor, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Lund University Hospital
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- 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.
This project will examine whether long-term consumption of healthy Nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. The study will be performed with the aim to achieve a substantial body weight loss in the first phase by prescribing a standardized low caloric dietary formula. The follow-up phase will be a body weight-maintenance period and the subjects will be randomised to a healthy Nordic diet group and a control diet group. During the study body weight will be monitored and other measurements will include insulin sensitivity, blood lipids and inflammation markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nordic diet | Active comparator | Other: Nordic diet |
| Control diet | Other | Other: Control diet |
Who may qualify
- Ages
- 25 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 25-67 years, BMI 30-40 kg/m2, waist circumference men >102cm and women > 88cm or sagittal abdominal diameter men >22cm and women >20cm, stable body weight
Key exclusion criteria (1 listed)
- glucose >7.0 mmol/l, B-Hb1aC >48 mmol/L, triglycerides >4 mmol/l, total cholesterol >8 mmol/l, bloodpressure >160/100 mmHg, chronic disease, gastro-intestinal disease, hyper-/hypothyroidism, alcohol abuse, cancer, gastric bypass operation, gluten allergy, lactose intolerance, pregnancy
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 |
|---|---|---|
| Nordic diet | Other | Nordic diet |
| Control diet | Other | Control diet |
Primary outcome
Change in sagittal abdominal diameter
Time frame: Change from baseline to month 6, 12, 18, 24
Change in body weight
Time frame: Change from baseline to month 6, 12, 18, 24
6 secondary outcomes
Insulin sensitivity (HOMA-IR)
Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Body fat and body lean mass (BIA)
Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Blood lipids
Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Blood pressure
Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Markers of kidney and liver function
Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Markers of inflammation and endothelial function
Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
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 12 May 2020.
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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 Nordic diet in people with Obesity and Cardiovascular Risk Factor, 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 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 12 May 2020. 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?
Change in sagittal abdominal diameter (time frame: Change from baseline to month 6, 12, 18, 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.