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Completed

NCT Number: NCT00379548

Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study

We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of developing a pro-inflammatory state that may contribute to the development of heart disease and diabetes when they change from a traditional Asian diet to a typical Western diet. These inflammatory responses will be reflected by the activation of monocytes as measured by protein kinase C (PKC), a known activator of monocytes.

We also hypothesize that the changes of these inflammatory responses in the gingival crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and monocytes.

Specific aims:

1. To compare the inflammatory responses (primarily PKC activation in monocytes), between Far-East Asian Americans and Caucasian Americans, when they change from a traditional Asian diet to a typical American diet. 2. To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).

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Key information

Conditions

Diabetes Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Disease Periodontal Diseases Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian or Far-East Asian decent
  • Ages between 25 - 55 years old
  • Has family history of diabetes defined as having a first degree relative diagnosed with diabetes mellitus, and/or medical history of gestational diabetes (GDM), impaired fasting glucose(IFG) and impaired glucose tolerance (IGT)
  • BMI of 18.5 - 25.0 kg/m2
  • Agree to maintain constant physical activity levels for the duration of the study
  • Agree to utilize contraception for the duration of the study (for female subjects)
  • Have a minimum of 12 natural teeth
  • Scoring of 2 or more on dental screening questionnaire (See appendix)
  • Ability to communicate in English

Exclusion criteria

  • Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
  • History of diabetes
  • Current Smokers (including those who quit < 1 year)
  • Heavy alcohol drinkers, defined as drinking more than 7 drinks/week. Those who drink alcohol will need to be reported and documented. They will be asked to maintain the levels of alcohol consumption throughout the study.
  • Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders
  • History of food allergies or to any food products in the diet menu.
  • Enrolled in another investigational study within 1 month prior to screening for this study
  • Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
  • Pregnancy or breasting feeding
  • Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
  • Chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year
  • On medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications. Daily multivitamins are permitted, excluding pharmacological doses of anti- oxidants will not be allowed.
  • Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.

Treatment and study plan

2 groups of population responding to 2 types of diets

Behavioral

Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.

Primary outcomes

  1. Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid

    Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

  2. Lipid profiles

    Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

  3. Blood glucose levels

    Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

  4. Body Fat percentage assessed by Dual X-ray Absorption

    Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

  5. Insulin resistance assessed by HOMA

    Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Sunstar, Inc.

Registry information

Official study title

A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets

Important dates

Study start
2005
Primary completion
2008
Study completion
2014
First posted
Sep 22, 2006
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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