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

NCT00379548 | Completed DMC

• 1 other identifier: 04-47
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).

Conditions

Diabetes; Insulin Resistance; Inflammation; Cardiovascular Disease; Periodontal Disease

Outcome Measures

Primary Outcomes (5)

• Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid

  before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

• Lipid profiles

  before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

• Blood glucose levels

  before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

• Body Fat percentage assessed by Dual X-ray Absorption

  before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

• Insulin resistance assessed by HOMA

  before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

Study Arms (2)

1

NO INTERVENTION

Control group- subjects are on the Asian diet for the entire duration of the study

2

EXPERIMENTAL

Asian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study.

Behavioral: 2 groups of population responding to 2 types of diets

Interventions

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.

2

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Sunstar, Inc.: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Hsu WC, Lau KH, Matsumoto M, Moghazy D, Keenan H, King GL. Improvement of insulin sensitivity by isoenergy high carbohydrate traditional Asian diet: a randomized controlled pilot feasibility study. PLoS One. 2014 Sep 16;9(9):e106851. doi: 10.1371/journal.pone.0106851. eCollection 2014.

  PMID: 25226279 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Inflammation; Cardiovascular Diseases; Periodontal Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• George L King, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: November 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2014
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)