Diet, Diabetes and Periodontitis

September 25, 2018 updated by: Cecilia Widen, Kristianstad University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
    • Skåne
      • Kristianstad, Skåne, Sweden, 29188
        • University of Kristianstad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Baseline
No dietary changes.
Dietary supplement: Comparison of Diets
Okinawan-based Nordic Diet and Control Diet
Placebo Comparator: Comparison of Diets
Okinawan-based Nordic Diet or Control Diet.
Dietary supplement: Comparison of Diets
Okinawan-based Nordic Diet and Control Diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline, 2, 4, and 26 weeks
Changes in levels of HbA1c (mmol/mol) in serum before and after study procedures
Baseline, 2, 4, and 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pro-inflammatory cytokines
Time Frame: Baseline, 2, 4, and 26 weeks
Change in levels of pro-inflammatory cytokines (pg/ml) in serum and gingival fluid in relation to gingival bleeding, before and after study procedures
Baseline, 2, 4, and 26 weeks
Gingivitis
Time Frame: Baseline, 2, 4, and 26 weeks
Changes in the extent of gingivitis, as determined by the severity of gingival bleeding (%), before and after the study procedures
Baseline, 2, 4, and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kristianstad University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/540

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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