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Clinical Trials/NCT03407508
NCT03407508UnknownPhase 1

Control of Diabetes and Periodontitis Through a New Anti-inflammatory Nordic Diet

Kristianstad University1 site in 1 country80 target enrollmentStarted: October 17, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
80
Locations
1
Primary Endpoint
HbA1c

Study Overview

Brief 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. 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Baseline

Placebo Comparator

No dietary changes.

Intervention: Comparison of Diets (Dietary Supplement)

Comparison of Diets

Placebo Comparator

Okinawan-based Nordic Diet or Control Diet.

Intervention: Comparison of Diets (Dietary Supplement)

Outcomes

Primary Outcomes

HbA1c

Time Frame: Baseline, 2, 4, and 26 weeks

Changes in levels of HbA1c (mmol/mol) in serum before and after study procedures

Secondary Outcomes

  • Pro-inflammatory cytokines(Baseline, 2, 4, and 26 weeks)
  • Gingivitis(Baseline, 2, 4, and 26 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecilia Widen

Principal Investigator

Kristianstad University

Study Sites (1)

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