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

Primary Purpose

Diabetes, Insulin Resistance, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 groups of population responding to 2 types of diets
Sponsored by
Joslin Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Caucasian or Far-East Asian decent
  2. Ages between 25 - 55 years old
  3. 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)
  4. BMI of 18.5 - 25.0 kg/m2
  5. Agree to maintain constant physical activity levels for the duration of the study
  6. Agree to utilize contraception for the duration of the study (for female subjects)
  7. Have a minimum of 12 natural teeth
  8. Scoring of 2 or more on dental screening questionnaire (See appendix)
  9. Ability to communicate in English

Exclusion Criteria:

  1. Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
  2. History of diabetes
  3. Current Smokers (including those who quit < 1 year)
  4. 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.
  5. Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders
  6. History of food allergies or to any food products in the diet menu.
  7. Enrolled in another investigational study within 1 month prior to screening for this study
  8. Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
  9. Pregnancy or breasting feeding
  10. Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
  11. Chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year
  12. 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.
  13. Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.

Sites / Locations

  • Joslin Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid
Lipid profiles
Blood glucose levels
Body Fat percentage assessed by Dual X-ray Absorption
Insulin resistance assessed by HOMA

Secondary Outcome Measures

Full Information

First Posted
September 21, 2006
Last Updated
March 17, 2017
Sponsor
Joslin Diabetes Center
Collaborators
Sunstar, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00379548
Brief Title
Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
Official Title
A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Sunstar, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Insulin Resistance, Inflammation, Cardiovascular Disease, Periodontal Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Control group- subjects are on the Asian diet for the entire duration of the study
Arm Title
2
Arm Type
Experimental
Arm Description
Asian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study.
Intervention Type
Behavioral
Intervention Name(s)
2 groups of population responding to 2 types of diets
Intervention Description
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 Outcome Measure Information:
Title
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
Title
Lipid profiles
Time Frame
before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Title
Blood glucose levels
Time Frame
before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Title
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
Title
Insulin resistance assessed by HOMA
Time Frame
before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L King, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25226279
Citation
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.
Results Reference
derived

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

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