Diabetes MellitusPhase 1/2NCT03407508
Diet, Diabetes and Periodontitis
A Phase 1/2 study testing Comparison of Diets in people with Diabetes Mellitus and Gingivitis, run by Kristianstad University at 1 site in Sweden.
Trial summary
There is a significant and growing interest in nutrition and health in the general population and there is also, paradoxically, an increasing problem with obesity and general debilitating conditions of affluence, such as type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Gingivitis
- What is being tested?
- Comparison of Diets
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 17 Oct 2018to Dec 2019
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum 20 teeth
- HbA1c = 60-80 mmol/mol (diabetics), HbA1c < 42 mmol/mol (control)
- be able to receive food delivery monday, wednesday, friday
- Scandinavian background
Who cannot join
- use of tobacco products
- pregnancy
- lactose, celiac- or garlic intolerance
- blood pressure ≥ 180 mm Hg
- have visited dental clinic within one month Before study start or currently are undergoing dental/dental hygienist treatment
- have rheumatoid arthritis
- for Medical reasons need treatment with antibiotics or who has been treated with antiobiotics within one month before study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Control of Diabetes and Periodontitis Through a New Anti-inflammatory Nordic Diet
There is a significant and growing interest in nutrition and health in the general population and there is also, paradoxically, an increasing problem with obesity and general debilitating conditions of affluence, such as type 2 diabetes mellitus. Igelösa Life Science AB has developed a modified Okinawan-based Nordic Diet (OBND) diet based on evidence primarily from the diet of the long-lived and healthy Okinawa population. The diet includes fish and whole grains, with a high level of vegetables, but is low in fat. In 2016, a clinical nutrition study was carried out at Kristianstad University with the intention to determine if the OBND resulted in reductions/changes in clinical and medical markers of importance for treatment of diabetes mellitus and gingivitis/periodontitis. The diet had a positive impact on the clinical progress of otherwise debilitating conditions such as diabetes and the health benefits on clinical parameters was extremely rapid, that is, within two weeks. Not only did the patients with type 2 diabetes receive the OBND, their partners were also offered the same option. This is a key innovation and the participants stated that it was a great support, which facilitated adherence and promotes the long-term impact on health. Ingrained habits such as poor diet, can only be defeated by a concerted team effort and our work to date provides a glimpse of the potential benefits to Sweden and the rest of the developed world through this shared approach.
Initial studies have shown promising effects of the OBND on both diabetes and periodontal conditions. The objective of this study is to compare the OBND to the current recommended standard diet. Assuming the study provides positive evidence of health impact due to improved food quality, it will also be seen that the production and delivery of such 'healthy-living' meals will be of commercial interest for industry. The mission is to offer an evidence-based natural food alternative that both prevents disease and improves the health status of individuals with diabetes. The long-term goal is to design efficient and effective products that will protect against diabetes and other chronic diseases. The combination of scientific credibility and commercial interests may be a key factor to transfer the new knowledge about healthy dieting into actual improvements in public health.
Read the detailed description
The project has one main goal: to perform a clinical trial to compare the OBND with standard of care diet. The outcome of the clinical trial will be analyzed in the areas: medicine/odontology, sensory science, nursing, public health and health economics.
Study objectives:
- To assess if the consumption of the designated diet results in added medical/dental health outcome for the OBND in comparison to standard of care diet. The study is a randomized case control clinical trial.
- To perform cost-effectiveness analyses comparing costs and health benefits for the test and control diets with focus on individuals with type 2 diabetes mellitus and otherwise healthy individuals living in close relationship to those with diabetes.
- To assess consumer acceptance of the diet: (I) acceptance of the diets (questionnaire, focus groups and food diary), (II) acceptability of the diet in relation to taste of the diet, and the prospect of adopting the diet in everyday life, and (III) sensory analysis of identical dishes prepared according to the OBND and the standard of care diet.
Study design The study design is a randomized double-blinded clinical trial with four subgroups including 20 individuals per study group.
Test Group A: OBND, individuals diagnosed with type 2 diabetes (T2D) with a need for insulin intake
Test Group B: OBND, relatives who do not have T2D
Control Group C: Standard of care diet, individuals diagnosed with T2D with a need for insulin intake
Control Group D: Standard of care diet, relatives who do not have T2D
Based on the above reported studies and available data on blood sugar and lipid values, the investigators have identified that 18 individuals in each group will provide adequate statistical power (alpha=0.05, beta=0.85). While lost to follow up occurs, the investigators will enroll 20 individuals in each group. Thus, a total of 80 study individuals (test and control) will be enrolled. Data analyses will be performed according to per protocol as well as per intent to treat. Clinical examination procedures in medicine and dentistry will follow principles of good clinical practice. Study group assignment will be based on a randomization using the SPSS statistics package. A pre-baseline examination will be performed to ensure that all study individuals fulfill study requirements. The investigators will monitor that study individuals are compliant to protocol.
Study time schedule The study design includes a pre-baseline study examination two weeks before study start to ensure that study individuals meet the criteria for study participation and to control for Hawthorne effects. Study individuals will be enrolled in groups of 8 to 10 individuals and re-examined at baseline. The primary study endpoint is the third examination will be performed 4 weeks after baseline examination. A follow-up examination will occur after 6 months (plus/minus 14 days). All study enrollments will be completed within one month. Study individuals will receive phone calls during the study period to encourage compliance and respond to specific questions.
- Conditions
- Diabetes Mellitus, Gingivitis
- Being tested
- Comparison of Diets
- Medical subject headings
- Diabetes Mellitus, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of DietsDietary supplement
Okinawan-based Nordic Diet and Control Diet
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Placebo comparator | No dietary changes. Receives: Dietary Supplement: Comparison of Diets |
| Comparison of Diets | Placebo comparator | Okinawan-based Nordic Diet or Control Diet. Receives: Dietary Supplement: Comparison of Diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Changes in levels of HbA1c (mmol/mol) in serum before and after study procedures
Measured: Baseline, 2, 4, and 26 weeks
Secondary outcomes (2)
Pro-inflammatory cytokines
Change in levels of pro-inflammatory cytokines (pg/ml) in serum and gingival fluid in relation to gingival bleeding, before and after study procedures
Measured: Baseline, 2, 4, and 26 weeks
Gingivitis
Changes in the extent of gingivitis, as determined by the severity of gingival bleeding (%), before and after the study procedures
Measured: Baseline, 2, 4, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start17 Oct 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristianstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Widen, Kristianstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407508
- Sponsor's protocol ID
- 2017/540
- Status last verified
- Sep 2018
- First submitted
- 3 Jan 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Diabetes and Periodontitis Through a New Anti-inflammatory Nordic Diet
- ClinicalTrials.gov ID
- NCT03407508
- Acronym / sponsor ID
- 2017/540
- Conditions
- Diabetes Mellitus, Gingivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kristianstad UniversityUniversity, hospital or other
- Study start
- 17 Oct 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Jan 2018 (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.
There is a significant and growing interest in nutrition and health in the general population and there is also, paradoxically, an increasing problem with obesity and general debilitating conditions of affluence, such as type 2 diabetes mellitus. Igelösa Life Science AB has developed a modified Okinawan-based Nordic Diet (OBND) diet based on evidence primarily from the diet of the long-lived and healthy Okinawa population. The diet includes fish and whole grains, with a high level of vegetables, but is low in fat. In 2016, a clinical nutrition study was carried out at Kristianstad University with the intention to determine if the OBND resulted in reductions/changes in clinical and medical markers of importance for treatment of diabetes mellitus and gingivitis/periodontitis. The diet had a positive impact on the clinical progress of otherwise debilitating conditions such as diabetes and the health benefits on clinical parameters was extremely rapid, that is, within two weeks. Not only did the patients with type 2 diabetes receive the OBND, their partners were also offered the same option. This is a key innovation and the participants stated that it was a great support, which facilitated adherence and promotes the long-term impact on health. Ingrained habits such as poor diet, can only be defeated by a concerted team effort and our work to date provides a glimpse of the potential benefits to Sweden and the rest of the developed world through this shared approach.
Initial studies have shown promising effects of the OBND on both diabetes and periodontal conditions. The objective of this study is to compare the OBND to the current recommended standard diet. Assuming the study provides positive evidence of health impact due to improved food quality, it will also be seen that the production and delivery of such 'healthy-living' meals will be of commercial interest for industry. The mission is to offer an evidence-based natural food alternative that both prevents disease and improves the health status of individuals with diabetes. The long-term goal is to design efficient and effective products that will protect against diabetes and other chronic diseases. The combination of scientific credibility and commercial interests may be a key factor to transfer the new knowledge about healthy dieting into actual improvements in public health.
Detailed description
The project has one main goal: to perform a clinical trial to compare the OBND with standard of care diet. The outcome of the clinical trial will be analyzed in the areas: medicine/odontology, sensory science, nursing, public health and health economics.
Study objectives:
- To assess if the consumption of the designated diet results in added medical/dental health outcome for the OBND in comparison to standard of care diet. The study is a randomized case control clinical trial.
- To perform cost-effectiveness analyses comparing costs and health benefits for the test and control diets with focus on individuals with type 2 diabetes mellitus and otherwise healthy individuals living in close relationship to those with diabetes.
- To assess consumer acceptance of the diet: (I) acceptance of the diets (questionnaire, focus groups and food diary), (II) acceptability of the diet in relation to taste of the diet, and the prospect of adopting the diet in everyday life, and (III) sensory analysis of identical dishes prepared according to the OBND and the standard of care diet.
Study design The study design is a randomized double-blinded clinical trial with four subgroups including 20 individuals per study group.
Test Group A: OBND, individuals diagnosed with type 2 diabetes (T2D) with a need for insulin intake
Test Group B: OBND, relatives who do not have T2D
Control Group C: Standard of care diet, individuals diagnosed with T2D with a need for insulin intake
Control Group D: Standard of care diet, relatives who do not have T2D
Based on the above reported studies and available data on blood sugar and lipid values, the investigators have identified that 18 individuals in each group will provide adequate statistical power (alpha=0.05, beta=0.85). While lost to follow up occurs, the investigators will enroll 20 individuals in each group. Thus, a total of 80 study individuals (test and control) will be enrolled. Data analyses will be performed according to per protocol as well as per intent to treat. Clinical examination procedures in medicine and dentistry will follow principles of good clinical practice. Study group assignment will be based on a randomization using the SPSS statistics package. A pre-baseline examination will be performed to ensure that all study individuals fulfill study requirements. The investigators will monitor that study individuals are compliant to protocol.
Study time schedule The study design includes a pre-baseline study examination two weeks before study start to ensure that study individuals meet the criteria for study participation and to control for Hawthorne effects. Study individuals will be enrolled in groups of 8 to 10 individuals and re-examined at baseline. The primary study endpoint is the third examination will be performed 4 weeks after baseline examination. A follow-up examination will occur after 6 months (plus/minus 14 days). All study enrollments will be completed within one month. Study individuals will receive phone calls during the study period to encourage compliance and respond to specific questions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | Placebo comparator | Dietary Supplement: Comparison of DietsNo dietary changes. |
| Comparison of Diets | Placebo comparator | Dietary Supplement: Comparison of DietsOkinawan-based Nordic Diet or Control Diet. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- minimum 20 teeth
- HbA1c = 60-80 mmol/mol (diabetics), HbA1c < 42 mmol/mol (control)
- be able to receive food delivery monday, wednesday, friday
- Scandinavian background
Key exclusion criteria (7 listed)
- use of tobacco products
- pregnancy
- lactose, celiac- or garlic intolerance
- blood pressure ≥ 180 mm Hg
- have visited dental clinic within one month Before study start or currently are undergoing dental/dental hygienist treatment
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 |
|---|---|---|
| Comparison of DietsOkinawan-based Nordic Diet and Control Diet | Dietary supplement | Baseline, Comparison of Diets |
Primary outcome
HbA1c
Time frame: Baseline, 2, 4, and 26 weeks
Changes in levels of HbA1c (mmol/mol) in serum before and after study procedures
2 secondary outcomes
Pro-inflammatory cytokines
Time frame: Baseline, 2, 4, and 26 weeks
Gingivitis
Time frame: Baseline, 2, 4, and 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
Related trials for Diabetes Mellitus
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Comparison of Diets in people with Diabetes Mellitus and Gingivitis, run by Kristianstad 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Sep 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Widén, PhD (+462503876, cecilia.widen@hkr.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline, 2, 4, and 26 weeks). 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 26 Sep 2018.