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临床试验/NCT03407508
NCT03407508Unknown1 期

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

Kristianstad University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月17日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
80
试验地点
2
主要终点
HbA1c

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Baseline

Placebo Comparator

No dietary changes.

干预措施: Comparison of Diets (Dietary Supplement)

Comparison of Diets

Placebo Comparator

Okinawan-based Nordic Diet or Control Diet.

干预措施: Comparison of Diets (Dietary Supplement)

结局指标

主要结局

HbA1c

时间窗: Baseline, 2, 4, and 26 weeks

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecilia Widen

Principal Investigator

Kristianstad University

研究点 (2)

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