Metabolic SyndromeNCT02075307
Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage
A study testing Blueberry Powder in people with Metabolic Syndrome and Insulin Resistance, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
Obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. These disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance, DNA Damage
- What is being tested?
- Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 4 Apr 2017
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30-60 years;
- BMI > 30;
- Blood pressure <140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).;
- Insulin resistance (HOMA/IR) > 2.0;
- Willing to restrict intake of high polyphenol-containing foods during the trial period;
- Willing to forego intake of nutritional supplements other than a multivitamin;
- Willing to maintain their current daily level of exercise throughout the study.
Who cannot join
- Known diabetes mellitus according to the 2013 ADA criteria;
- Medications known to affect glucose metabolism;
- Weight loss pharmacotherapy;
- Lipid-lowering medication;
- Untreated thyroid or chronic liver, renal, or cardiovascular disease;
- Smoking;
Show all 11Show fewer
- Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment.
- History of allergic reactions to blueberries.
- Any pathological condition known to alter white blood cell count over the previous 6 months;
- Exposure to drugs known to cause mutations or radiation within the previous 6 months;
- Alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital & Research Center Oakland
Oakland, California, 94609
About this study
Official title: Highbush Blueberries, the DNA-damage of Obesity, Somatic Mutations and Metabolic Syndrome
Obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. These disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. High levels of damage to the DNA that makes up our chromosomes have also been observed in obese people. It is possible that these two disturbances are connected. The goal of this project is to test this whether consumption of blueberries will improve these abnormalities.
Read the detailed description
Unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the United States, particularly among the obese. Insulin resistance and high levels of DNA damage commonly accompany obesity. There also appears to be a relationship between oxidative DNA-damage and biomarkers that characterize metabolic syndrome. The bioactivity of blueberries is usually attributed to their high content of polyphenolics which can reduce oxidative DNA damage. Since oxidative damage to mitochondrial DNA is a suggested causal factor leading to increased insulin resistance, we will test if blueberry consumption can be an ameliorative dietary factor for insulin resistance as well. If blueberry consumption both shifts metabolism away from insulin resistance and reduces DNA damage, it may be a useful tool to assist in understanding relationships between these two obesity-associated conditions.
- Conditions
- Metabolic Syndrome, Insulin Resistance, DNA Damage
- Being tested
- Blueberry Powder, Placebo
- Keywords
- insulin, diabetes, obesity, DNA damage, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry PowderDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Powder | Experimental | The intervention group will receive the Blueberry freeze-dried powder equivalent to 1 cup of whole Blueberries twice a day for 8 weeks (i.e. 2 cups/day). Receives: Dietary Supplement: Blueberry Powder |
| Placebo Powder | Placebo comparator | The placebo group will receive placebo powder in the same amounts for the same duration. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA damage in peripheral blood mononuclear cells
DNA double-stranded breaks (DSBs) will be measured.
Measured: Baseline and 2 months
Secondary outcomes (1)
Insulin resistance
Insulin resistance will be measured by a 2-hr glucose tolerance test.
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJan 2014
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council, USDA Agricultural Research Station in Albany, CA
- Responsible party
- Sponsor
- Investigators
- Bruce Ames, PhD, Principal investigator, Children's Hospital & Research Center at OaklandAshutosh Lal, MD, Principal investigator, Children's Hospital & Research Center at Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075307
- Sponsor's protocol ID
- 2012-033
- Status last verified
- Dec 2020
- First submitted
- 27 Feb 2014
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highbush Blueberries, the DNA-damage of Obesity, Somatic Mutations and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02075307
- Acronym / sponsor ID
- 2012-033
- Conditions
- Metabolic Syndrome, Insulin Resistance, DNA Damage
- Keywords
- insulin, diabetes, obesity, DNA damage, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council, USDA Agricultural Research Station in Albany, CA
- Study start
- Jan 2014
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 3 Mar 2014 (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.
Obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. These disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. High levels of damage to the DNA that makes up our chromosomes have also been observed in obese people. It is possible that these two disturbances are connected. The goal of this project is to test this whether consumption of blueberries will improve these abnormalities.
Detailed description
Unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the United States, particularly among the obese. Insulin resistance and high levels of DNA damage commonly accompany obesity. There also appears to be a relationship between oxidative DNA-damage and biomarkers that characterize metabolic syndrome. The bioactivity of blueberries is usually attributed to their high content of polyphenolics which can reduce oxidative DNA damage. Since oxidative damage to mitochondrial DNA is a suggested causal factor leading to increased insulin resistance, we will test if blueberry consumption can be an ameliorative dietary factor for insulin resistance as well. If blueberry consumption both shifts metabolism away from insulin resistance and reduces DNA damage, it may be a useful tool to assist in understanding relationships between these two obesity-associated conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Powder | Experimental | Dietary Supplement: Blueberry PowderThe intervention group will receive the Blueberry freeze-dried powder equivalent to 1 cup of whole Blueberries twice a day for 8 weeks (i.e. 2 cups/day). |
| Placebo Powder | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will receive placebo powder in the same amounts for the same duration. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 30-60 years;
- BMI > 30;
- Blood pressure <140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).;
- Insulin resistance (HOMA/IR) > 2.0;
- Willing to restrict intake of high polyphenol-containing foods during the trial period;
Key exclusion criteria (11 listed)
- Known diabetes mellitus according to the 2013 ADA criteria;
- Medications known to affect glucose metabolism;
- Weight loss pharmacotherapy;
- Lipid-lowering medication;
- Untreated thyroid or chronic liver, renal, or cardiovascular 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 |
|---|---|---|
| Blueberry Powder | Dietary supplement | Blueberry Powder |
| Placebo | Dietary supplement | Placebo Powder |
Primary outcome
DNA damage in peripheral blood mononuclear cells
Time frame: Baseline and 2 months
DNA double-stranded breaks (DSBs) will be measured.
1 secondary outcome
Insulin resistance
Time frame: Baseline and 2 months
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 23 Dec 2020.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Bruce Ames, PhD principal investigator
Children's Hospital & Research Center at Oakland
Ashutosh Lal, MD principal investigator
Children's Hospital & Research Center at Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Powder in people with Metabolic Syndrome and Insulin Resistance, run by UCSF Benioff Children's Hospital Oakland 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 7 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 23 Dec 2020. 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?
DNA damage in peripheral blood mononuclear cells (time frame: Baseline and 2 months). 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 23 Dec 2020.