DiabetesNCT00379548
Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
A study testing 2 groups of population responding to 2 types of diets in people with Diabetes and Insulin Resistance, run by Joslin Diabetes Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Insulin Resistance, Inflammation
- What is being tested?
- 2 groups of population responding to 2 types of diets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- Have a minimum of 12 natural teeth
- Scoring of 2 or more on dental screening questionnaire (See appendix)
- Ability to communicate in English
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets
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.
Read more
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).
- Being tested
- 2 groups of population responding to 2 types of diets
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Inflammation, Cardiovascular Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 groups of population responding to 2 types of dietsBehavioural
Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 2 groups of population responding to 2 types of diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid
Measured: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Lipid profiles
Measured: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Blood glucose levels
Measured: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Body Fat percentage assessed by Dual X-ray Absorption
Measured: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Insulin resistance assessed by HOMA
Measured: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2008
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstar, Inc.
- Responsible party
- Sponsor
- Investigators
- George L King, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379548
- Sponsor's protocol ID
- 04-47
- Status last verified
- Mar 2017
- First submitted
- 21 Sep 2006
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25226279
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets
- ClinicalTrials.gov ID
- NCT00379548
- Acronym / sponsor ID
- 04-47
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Sunstar, Inc.
- Study start
- Nov 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control group- subjects are on the Asian diet for the entire duration of the study |
| 2 | Experimental | Behavioral: 2 groups of population responding to 2 types of dietsAsian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 groups of population responding to 2 types of dietsIntervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study. | Behavioural | 2 |
Primary outcome
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
Lipid profiles
Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Blood glucose levels
Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
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
Insulin resistance assessed by HOMA
Time frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Derived from this study: PubMed 25226279Hsu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George L King, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 groups of population responding to 2 types of diets in people with Diabetes and Insulin Resistance, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.