Nutrition, Oral Health and Type 2 Diabetes

NCT02916589 | Completed Phase 1

• 1 other identifier: 2016/582
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity continues to pose major public health challenges worldwide with cardiovascular damage, hypertension and diabetes as possible subsequent conditions. The obese are at risk for mortality and morbidity as they suffer from a high level of immune sensitivity with consequences related to damage to the circulation and microvasculature. The immune process itself is modulated by cytokines, which are small proteins which can modulate the spectrum of the inflammatory process. These proteins may act as biomarkers in the mouth. Diabetes is also a consequence of sustained obesity and this condition can strongly influence immune status. Diabetes is characterized by the failure to produce the hormone insulin or a loss of sensitivity to insulin. Without insulin high blood glucose results in the release of a series of pro-inflammatory factors, which lead to pathological processes in several organs leading to high mortality and morbidity. Periodontitis, a common complication of diabetes, is an inflammatory condition of the soft tissue of the periodontium, causing alveolar bone loss. The accessibility of the oral cavity facilitates the study of early inflammatory processes. Changes in diet may reduce inflammation, controlling gingival inflammation as well as clinical treatment. Since 2004 Igelösa Life Science AB has developed a modified Nordic diet based on evidence, primarily from the Japanese island of Okinawa, where the world's oldest and most healthy people live. In this study we will investigate the association between Igelösa dietary intake and measurements of inflammation in 30 overweight individuals with or without other systemic diseases.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in the extent of gingivitis, as determined by the severity of gingival bleeding, Before and after study procedures.

  Once a week over two weeks.

Secondary Outcomes (1)

• Change in levels of proinflammatory cytokines in serum and gingival fluid in relation to ginigival bleeding, Before and after study procedures.

  Once a week over two weeks.

Study Arms (2)

Baseline

PLACEBO COMPARATOR

The subjects will start with one week eating their normal diet.

Dietary Supplement: Diet

Igelosa Diet

ACTIVE COMPARATOR

After one week the subjects will be provided the Igelosa Diet.

Dietary Supplement: Diet

Interventions

Diet DIETARY_SUPPLEMENT

Baseline; Igelosa Diet

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 18 teeth
• BMI\>30

You may not qualify if:

• on anti-inflammatory medication
• current treatment with antibiotics or intake of antibiotics 3 months before participating in the study
• pregnancy

Sponsors & Collaborators

• Kristianstad University: lead

Study Sites (1)

University of Kristianstad

Kristianstad, Skåne County, 29188, Sweden

Location

MeSH Terms

Conditions

Inflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Brita Larsson

  Kristianstad University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

SE (1)