Metabolic Syndrome XNCT02542176
Effects of a Standardized Freeze-dried Grape Powder on High Density Lipoprotein (HDL) Function in Metabolic Syndrome
A study testing Freeze-dried Whole Grape Powder in people with Metabolic Syndrome X, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of both chronic and acute grape ingestion in a population of men and women at higher risk for both type 2 diabetes and cardiovascular disease (metabolic syndrome). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Freeze-dried Whole Grape Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Mar 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 70 years
- Having metabolic syndrome, meaning that subjects have at least 3 of the following characteristics:
- Waist circumference ≥ 102 cm for men and ≥ 88 cm for women
- Triglycerides ≥ 150 mg/dL
- HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women
- Blood pressure ≥ 130/85 mm Hg or taking an anti-hypertensive medication
- Fasting blood glucose ≥ 100 mg/dL
Who cannot join
- Do not fulfill the classification of metabolic syndrome
- History of diabetes mellitus, cardiovascular disease, stroke, renal problems, liver disease, endocrine disorder, inborn error of metabolism, eating disorder or cancer.
- Weight loss greater than 10% of body weight over preceding 4 weeks.
- Taking high-dose aspirin (≥150 mg/day) or anti-inflammatory prescriptions, or any triglyceride- or glucose-lowering prescriptions or supplements, such as insulin, sodium-glucose transport protein-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, Fibrates (e.g., fenofibrates, gemfibrozil), Niacin (e.g., high dose nicotinic acid, Niaspan) Sulphonylureas (e.g., Glucotrol, Amaryl), Thiazolidinediones (e.g., Avandia, ACTOS, Rezulin), Meglitinides (e.g., Prandin, Starlix), Biguanides (e.g., Metformin), Alpha-glucosidase inhibitors (e.g., Precose, Glyset), dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., Januvia, Onglyza), prescription fish oil (e.g., Lovaza, Vascepa), high dose chromium, high dose fish oil, or cinnamon supplements etc.
- Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, blood pressure higher than 160/100 mmHg, and waist circumference higher than 200 cm.
- Allergy to coconut, milk, wheat, grapes or an allergy/intolerance to the placebo ingredients.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Pilot Study: Effects of a Standardized Freeze-dried Grape Powder on High Density Lipoprotein (HDL) Function in Metabolic Syndrome
The purpose of this study is to evaluate the effects of both chronic and acute grape ingestion in a population of men and women at higher risk for both type 2 diabetes and cardiovascular disease (metabolic syndrome).
Read the detailed description
This study will involve a 2-week "run-in" period and two 4-week "intervention" phases separated by a 3 week "washout" non-intervention phase (for a total of 13 weeks). At the start of each 4-week intervention period, subjects will be asked to participate in a "postprandial challenge" test. Subjects will be asked to first follow a 2-week run-in control period consuming habitual diets but refraining from consuming polyphenol-rich foods/beverages, including tea, berries, grapes, juices, and wine. Subjects will then be asked to consume 60 g of grape powder or placebo in random order, each for a 4-week intervention period, separated by a 3-week washout period. Subjects will be asked to prepare powder by mixing with water at breakfast (30 g) and dinner (30 g) and consume immediately after mixing (or within 30 minutes). During each 4-week intervention period, subjects will be asked to refrain from consuming polyphenol-rich foods/beverages. During the washout period subjects will not be asked to consume the powder, but should abstain from consuming polyphenol-rich foods/beverages. The grape powder is made from a composite of fresh red, green and black California grapes, based on actual consumption patterns of consumers. It is a mix of seeded and seedless varieties that have been frozen, ground with food-quality dry ice, freeze-dried, and re-ground. Subjects will also be asked to maintain normal diet and exercise habits throughout the study, with the exception being the consumption of polyphenol-rich foods/beverages. Subjects will be asked to complete a 5-day dietary record (including 1 weekend day) and a 7-day physical activity diary at the baseline and end of each intervention period. Subjects will come to the University of Connecticut Nutrition Department once every other week (biweekly) to pick up the powder (in packets), which needs to be kept frozen until consumption.
For the postprandial challenge tests, subjects will be asked to fast overnight (12 hours) and then will be given a coconut oil-based lactose-free milkshake (1 g fat/kg body weight), containing 60 g of either placebo or grape powder. Subjects will be asked to spend the test day in the laboratory in a rested state and, with the exception of water, will not be permitted to consume any additional food or beverages during the 6 hours after consuming the milkshake. Subjects will be asked to abstain from alcohol and strenuous physical activity 24-hours prior to the postprandial test. To standardize short-term fat intake, subjects will be given recipes and instructed to consume a low-fat evening meal (< 10 g fat) the night prior to postprandial tests. Subjects will also be asked to complete a 1-day food record for the day prior to the postprandial tests.
- Conditions
- Metabolic Syndrome X
- Being tested
- Freeze-dried Whole Grape Powder, Grape Powder Placebo
- Keywords
- Metabolic Syndrome, Grape, HDL, Lipoproteins
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried Whole Grape PowderOther
60 g of whole grape powder for 4 weeks
Grape Powder PlaceboOther
60 g of grape powder placebo for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Freeze-dried Whole Grape Powder | Experimental | Not described Receives: Other: Freeze-dried Whole Grape Powder |
| Grape Powder Placebo | Placebo comparator | Not described Receives: Other: Grape Powder Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasted HDL-cholesterol
Measurement of plasma HDL-cholesterol (mg/dL) at the end of each 4-week intervention arms.
Measured: 13 weeks
Secondary outcomes (3)
Fasted apolipoprotein B-depleted serum cholesterol efflux capacity
Measurement of fasted apolipoprotein B-depleted serum cholesterol efflux capacity (% cholesterol efflux) from macrophages loaded with tritium(3H)-labeled-cholesterol at the end of each 4-week intervention arms. Results will be expressed as percent efflux calculated as disintegrations per minute of [3H]-cholesterol in medium ÷ ([3H]-cholesterol in medium + [3H]-cholesterol remaining in cells) x 100.
Measured: 13 weeks
Postprandial HDL anti-inflammatory activity
Adhesion molecule expression (micrograms/L) will be measured after incubation of human endothelial cells with HDL isolated from pre-test meal (baseline), 3 hours post-test meal, and 6 hours post-test meal time points.
Measured: On first day of each intervention arm up to 6 hours after test meal
Postprandial HDL antioxidant activity
Paraoxonase-1 enzyme activity towards phenyl acetate (kU/L) measured in serum from pre-test meal (baseline), 3 hours post-test meal, and 6 hours post-test meal time points.
Measured: On first day of each intervention arm up to 6 hours after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2018
- Study completionMar 2018
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 Metabolic Syndrome XStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- California Table Grape Commission
- Responsible party
- Principal investigator, Christopher Blesso, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542176
- Sponsor's protocol ID
- 150888
- Status last verified
- Mar 2018
- First submitted
- 1 Sep 2015
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Millar CL, Duclos Q, Garcia C, Norris GH, Lemos BS, DiMarco DM, Fernandez ML, Blesso CN. Effects of Freeze-Dried Grape Powder on High-Density Lipoprotein Function in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Study. Metab Syndr Relat Disord. 2018 Nov;16(9):464-469. doi: 10.1089/met.2018.0052. Epub 2018 Aug 21.
PubMed 30129815
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Effects of a Standardized Freeze-dried Grape Powder on High Density Lipoprotein (HDL) Function in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02542176
- Acronym / sponsor ID
- 150888
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic Syndrome, Grape, HDL, Lipoproteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- California Table Grape Commission
- Study start
- Oct 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Sep 2015 (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.
The purpose of this study is to evaluate the effects of both chronic and acute grape ingestion in a population of men and women at higher risk for both type 2 diabetes and cardiovascular disease (metabolic syndrome).
Detailed description
This study will involve a 2-week "run-in" period and two 4-week "intervention" phases separated by a 3 week "washout" non-intervention phase (for a total of 13 weeks). At the start of each 4-week intervention period, subjects will be asked to participate in a "postprandial challenge" test. Subjects will be asked to first follow a 2-week run-in control period consuming habitual diets but refraining from consuming polyphenol-rich foods/beverages, including tea, berries, grapes, juices, and wine. Subjects will then be asked to consume 60 g of grape powder or placebo in random order, each for a 4-week intervention period, separated by a 3-week washout period. Subjects will be asked to prepare powder by mixing with water at breakfast (30 g) and dinner (30 g) and consume immediately after mixing (or within 30 minutes). During each 4-week intervention period, subjects will be asked to refrain from consuming polyphenol-rich foods/beverages. During the washout period subjects will not be asked to consume the powder, but should abstain from consuming polyphenol-rich foods/beverages. The grape powder is made from a composite of fresh red, green and black California grapes, based on actual consumption patterns of consumers. It is a mix of seeded and seedless varieties that have been frozen, ground with food-quality dry ice, freeze-dried, and re-ground. Subjects will also be asked to maintain normal diet and exercise habits throughout the study, with the exception being the consumption of polyphenol-rich foods/beverages. Subjects will be asked to complete a 5-day dietary record (including 1 weekend day) and a 7-day physical activity diary at the baseline and end of each intervention period. Subjects will come to the University of Connecticut Nutrition Department once every other week (biweekly) to pick up the powder (in packets), which needs to be kept frozen until consumption.
For the postprandial challenge tests, subjects will be asked to fast overnight (12 hours) and then will be given a coconut oil-based lactose-free milkshake (1 g fat/kg body weight), containing 60 g of either placebo or grape powder. Subjects will be asked to spend the test day in the laboratory in a rested state and, with the exception of water, will not be permitted to consume any additional food or beverages during the 6 hours after consuming the milkshake. Subjects will be asked to abstain from alcohol and strenuous physical activity 24-hours prior to the postprandial test. To standardize short-term fat intake, subjects will be given recipes and instructed to consume a low-fat evening meal (< 10 g fat) the night prior to postprandial tests. Subjects will also be asked to complete a 1-day food record for the day prior to the postprandial tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried Whole Grape Powder | Experimental | Other: Freeze-dried Whole Grape Powder |
| Grape Powder Placebo | Placebo comparator | Other: Grape Powder Placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 30 to 70 years
- Having metabolic syndrome, meaning that subjects have at least 3 of the following characteristics:
- Waist circumference ≥ 102 cm for men and ≥ 88 cm for women
- Triglycerides ≥ 150 mg/dL
- HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women
Key exclusion criteria (6 listed)
- Do not fulfill the classification of metabolic syndrome
- History of diabetes mellitus, cardiovascular disease, stroke, renal problems, liver disease, endocrine disorder, inborn error of metabolism, eating disorder or cancer.
- Weight loss greater than 10% of body weight over preceding 4 weeks.
- Taking high-dose aspirin (≥150 mg/day) or anti-inflammatory prescriptions, or any triglyceride- or glucose-lowering prescriptions or supplements, such as insulin, sodium-glucose transport protein-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, Fibrates (e.g., fenofibrates, gemfibrozil), Niacin (e.g., high dose nicotinic acid, Niaspan) Sulphonylureas (e.g., Glucotrol, Amaryl), Thiazolidinediones (e.g., Avandia, ACTOS, Rezulin), Meglitinides (e.g., Prandin, Starlix), Biguanides (e.g., Metformin), Alpha-glucosidase inhibitors (e.g., Precose, Glyset), dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., Januvia, Onglyza), prescription fish oil (e.g., Lovaza, Vascepa), high dose chromium, high dose fish oil, or cinnamon supplements etc.
- Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, blood pressure higher than 160/100 mmHg, and waist circumference higher than 200 cm.
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 |
|---|---|---|
| Freeze-dried Whole Grape Powder60 g of whole grape powder for 4 weeks | Other | Freeze-dried Whole Grape Powder |
| Grape Powder Placebo60 g of grape powder placebo for 4 weeks | Other | Grape Powder Placebo |
Primary outcome
Fasted HDL-cholesterol
Time frame: 13 weeks
Measurement of plasma HDL-cholesterol (mg/dL) at the end of each 4-week intervention arms.
3 secondary outcomes
Fasted apolipoprotein B-depleted serum cholesterol efflux capacity
Time frame: 13 weeks
Postprandial HDL anti-inflammatory activity
Time frame: On first day of each intervention arm up to 6 hours after test meal
Postprandial HDL antioxidant activity
Time frame: On first day of each intervention arm up to 6 hours after test meal
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 Mar 2018.
- Derived from this study: PubMed 30129815Millar CL, Duclos Q, Garcia C, Norris GH, Lemos BS, DiMarco DM, Fernandez ML, Blesso CN. Effects of Freeze-Dried Grape Powder on High-Density Lipoprotein Function in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Study. Metab Syndr Relat Disord. 2018 Nov;16(9):464-469. doi: 10.1089/met.2018.0052. Epub 2018 Aug 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried Whole Grape Powder in people with Metabolic Syndrome X, run by University of Connecticut 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 6 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 Mar 2018. 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?
Fasted HDL-cholesterol (time frame: 13 weeks). 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 NCT02542176, 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 23 Mar 2018.