Insulin ResistanceNCT02006394
Novel Dietary Interventions for Treating Insulin Resistance
A study testing Fish Oil, Polyphenol Capsules and Corn Oil Capsules in people with Insulin Resistance and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Insulin Resistance, Obesity, Metabolic Syndrome
- What is being tested?
- Fish Oil, Polyphenol Capsules and Corn Oil Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2013
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index (BMI): 30.0-40.9 kg/m^2
- Metabolic Syndrome
Who cannot join
- Diabetes
- Inflammatory diseases
- Eating disorders
- Pregnancy
- Known kidney, coronary, gastrointestinal or peripheral artery disease
- Smoking
Show all 11Show fewer
- Recent fish oil (>500mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/day) or polyphenol supplement use
- Recent weight change
- Strenuous exercise
- Fish/food allergies
- Current diabetic, lipid-lowering (fibrates, statins), anti-inflammatory, immune-suppressant, and/or anti-inflammatory hypertension medication use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.
- Conditions
- Insulin Resistance, Obesity, Metabolic Syndrome
- Being tested
- Fish Oil, Polyphenol Capsules, Corn Oil Capsules, Corn starch capsules, Reduced glycemic index bread products
- Keywords
- Inflammation, Monocytes
- Medical subject headings
- Insulin Resistance, Obesity, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
fish oil capsules
Polyphenol CapsulesDietary supplement
delphinidin polyphenol capsules
Corn Oil CapsulesDietary supplement
Corn Oil Capsules
Corn starch capsulesDietary supplement
Maltodextrin capsules
Reduced glycemic index bread productsOther
Made by Zone Labs
Market variety bread productsOther
placebo bread products
| Study group | Role | What they receive |
|---|---|---|
| Active Diet | Experimental | Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules. Receives: Dietary Supplement: Fish Oil; Dietary Supplement: Polyphenol Capsules; Other: Reduced glycemic index bread products |
| Placebo Diet | Placebo comparator | Market variety bread products, corn oil capsules, and corn starch capsules. Receives: Dietary Supplement: Corn Oil Capsules; Dietary Supplement: Corn starch capsules; Other: Market variety bread products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance
Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (1)
Change in inflammation biomarkers
Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Sears, University of California, San Diego
- Investigators
- Dorothy Sears, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006394
- Sponsor's protocol ID
- IRB #110549
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Dietary Interventions for Treating Insulin Resistance
- ClinicalTrials.gov ID
- NCT02006394
- Acronym / sponsor ID
- IRB #110549
- Conditions
- Insulin Resistance, Obesity, Metabolic Syndrome
- Keywords
- Inflammation, Monocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Dec 2013 (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.
Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Diet | Experimental | Dietary Supplement: Fish Oil, Dietary Supplement: Polyphenol Capsules, Other: Reduced glycemic index bread productsReduced glycemic index bread products, fish oil capsules, and polyphenol capsules. |
| Placebo Diet | Placebo comparator | Dietary Supplement: Corn Oil Capsules, Dietary Supplement: Corn starch capsules, Other: Market variety bread productsMarket variety bread products, corn oil capsules, and corn starch capsules. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI): 30.0-40.9 kg/m^2
- Metabolic Syndrome
Key exclusion criteria (11 listed)
- Diabetes
- Inflammatory diseases
- Eating disorders
- Pregnancy
- Known kidney, coronary, gastrointestinal or peripheral artery disease
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 |
|---|---|---|
| Fish Oilfish oil capsules | Dietary supplement | Active Diet |
| Polyphenol Capsulesdelphinidin polyphenol capsules | Dietary supplement | Active Diet |
| Corn Oil CapsulesCorn Oil Capsules | Dietary supplement | Placebo Diet |
| Corn starch capsulesMaltodextrin capsules | Dietary supplement | Placebo Diet |
| Reduced glycemic index bread productsMade by Zone Labs | Other | Active Diet |
| Market variety bread productsplacebo bread products | Other | Placebo Diet |
Primary outcome
Change in insulin resistance
Time frame: Baseline, 6 weeks, and 12 weeks
Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
1 secondary outcome
Change in inflammation biomarkers
Time frame: Baseline, 6 weeks, 12 weeks
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 12 Dec 2013.
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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.
Dorothy Sears, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil, Polyphenol Capsules and Corn Oil Capsules in people with Insulin Resistance and Obesity, run by University of California, San Diego 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 2 inclusion and 11 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 12 Dec 2013. 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. Some participants in this study may receive a placebo. 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?
Change in insulin resistance (time frame: Baseline, 6 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2013.