Diet, Diabetes and Periodontitis

NCT03407508 | Unknown Phase 1

• 1 other identifier: 2017/540
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Gingivitis

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

  Baseline, 2, 4, and 26 weeks

Secondary Outcomes (2)

• Pro-inflammatory cytokines

  Baseline, 2, 4, and 26 weeks

• Gingivitis

  Baseline, 2, 4, and 26 weeks

Study Arms (2)

Baseline

PLACEBO COMPARATOR

No dietary changes.

Dietary Supplement: Comparison of Diets

Comparison of Diets

PLACEBO COMPARATOR

Okinawan-based Nordic Diet or Control Diet.

Dietary Supplement: Comparison of Diets

Interventions

Comparison of Diets DIETARY_SUPPLEMENT

Okinawan-based Nordic Diet and Control Diet

Baseline; Comparison of Diets

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristianstad University: lead

Study Sites (1)

University of Kristianstad

Kristianstad, Skåne County, 29188, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Gingivitis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Cecilia Widén, PhD

CONTACT

+462503876; cecilia.widen@hkr.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 23, 2018
• Study Start: October 17, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

SE (1)