AnthocyaninsNCT03309982
Intestinal Inflammatory and Metabolic Responses to a High Fat Meal and Plant Polyphenol Blend
A study testing Plant polyphenol blend in people with Anthocyanins, run by Pharmanex at 1 site in United States.
Trial summary
This study will investigate the beneficial effects of supplementation with a plant polyphenol blend rich in anthocyanins on parameters of inflammation and metabolic responses following a challenge with a high-fat (HF) meal. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthocyanins
- What is being tested?
- Plant polyphenol blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 27 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
- Males and females
- Age between 18 - 35 years inclusive
- Subjects with BMI of 22 - 29.9 kg/m2
- Subjects who agree to discontinue the use of pre- and probiotic and/or polyphenol supplements from 4 weeks prior to the first and through the last study visit
- Subjects who agree to discontinue foods containing anthocyanins (such as blueberries, blackberries, bilberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries, and red wine) for at least 1 week prior to each visit.
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- Subjects with no known allergies to study product or components (bilberries, black currants, rice)
- Subjects willing to completely consume high-fat meal and assigned study product
- Subjects willing to consume a similar, low fat/low flavonoid \dinner the evening before each high-fat meal visit
- Subjects have given voluntary, written, informed consent to participate in the study
Who cannot join
- Age < 18 or > 35 years
- BMI < 22 or > 29.9 kg/m2
- Vegetarian or other dietary restrictions that would not allow the subject to consume the highfat meal
- Regularly participates in endurance exercise activities (e.g. marathon running, triathlons)
- Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg or systolic blood pressure ≥ 160 mmHg
- Screening serum triglycerides > 150 mg/dL
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- Screening fasting blood glucose < 50 mg/dL or > 100 mg/dL
- Current smoker or use of tobacco products within the past year
- Individuals who binge drink (alcohol intake ≥ 5 alcoholic drinks for males or ≥4 alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other)
- Substance abuse or dependence within the prior 60 days.
- Daily use of anti-inflammatory medications including NSAIDs and aspirin in the last 4 weeks
- Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
- History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism in the last 4 weeks
- History of stroke, hepatic, kidney, thyroid disease or cancer
- History of immune related disorders or Raynaud's disease
- Current clinically significant depression, anxiety or other psychiatric condition
- History of malabsorption or GI tract disorders
- History of GI surgeries (i.e. lapband, gastric bypass, etc.)
- Diarrhea or oral antibiotic intake within the last 4 weeks
- Weight change (> 5%) in the last 8 weeks
- Subject with known history of eating disorders such as bulimia, anorexia, or muscle dysmorphia
- Allergy or sensitivity to the study product or components of the high-fat meal
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Nutrition Department
Davis, California, 95616
About this study
Official title: A Randomized Placebo-controlled Cross-over Design Study Investigating the Effects of a Plant Polyphenol Blend on the Intestinal Inflammatory and Metabolic Responses to a High Fat Meal in Healthy Subjects
This study will investigate the beneficial effects of supplementation with a plant polyphenol blend rich in anthocyanins on parameters of inflammation and metabolic responses following a challenge with a high-fat (HF) meal.
The investigators will use a randomized crossover study to investigate the effects of: 1) placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists of English muffin bread, sausage, egg and cheese, obtained from US market and completed with palm fat. The total energy content of the high-fat meal is 1,026 Kcal with 70.5 g of fat (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g protein with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. The high-fat meal will be standard and it will not be adjusted for large and small participants.
- Conditions
- Anthocyanins
- Being tested
- Plant polyphenol blend, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant polyphenol blendDietary supplement
A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
PlaceboOther
A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
| Study group | Role | What they receive |
|---|---|---|
| Plant polyphenol blend | Experimental | The study product (4 g) consists of 3 g of a mix a maltodextrins, and 1 g of anthocyanin-rich plant polyphenol blend containing: 1) 100 mg bilberry extract; 2) 300 mg black currant extract; and 3) 600 mg black rice extract. Receives: Dietary Supplement: Plant polyphenol blend |
| Placebo | Placebo comparator | The placebo (4 g) consists of a mix of maltodextrins (3.85 g) and Red Dye No. 40 (0.125 g) and Blue Dye No. 1 (0.025 g). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plasma endotoxin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure endotoxin in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Secondary outcomes (28)
Change from baseline in plasma IL-6 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-6 in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma insulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure insulin in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma GLP-1 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure GLP-1 in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma GLP-2 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure GLP-2 in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma GIP at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure GIP in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma adiponectin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure adiponectin in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma leptin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure leptin in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma ghrelin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure ghrelin in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma triglycerides at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure triglycerides in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total cholesterol at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total cholesterol in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma HDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure HDL in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma LDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure LDL in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma zonulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure zonulin in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total polyphenols at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total polyphenols in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total anthocyanidins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total anthycyanidins in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total catechins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total catechins in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma glucose at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure glucose in plasma
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-8 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-8 in PBMC
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-10 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-10 in PBMC
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-1β at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-1β in PBMC
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-12p70 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-12p70 in PBMC
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC TNFa at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure TNFa in PBMC
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC NF-kB at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure NF-kB in PBMC
Measured: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in fingerstick triglycerides at 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure triglycerides
Measured: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick total cholesterol at 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure total cholesterol
Measured: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick HDL at 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure HDL
Measured: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick LDL at 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure LDL
Measured: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick glucose at 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure glucose
Measured: Baseline, and 15 minutes post high-fat meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start16 Oct 2017
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnthocyaninsStudies 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
- Crossover
- Model description
- A randomized placebo-controlled cross-over design study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Patricia Oteiza, PhD, University of California, Davis
- Investigators
- Patricia Oteiza, PhD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309982
- Sponsor's protocol ID
- 17-PHX-0002
- Status last verified
- Apr 2018
- First submitted
- 4 Oct 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Cross-over Design Study Investigating the Effects of a Plant Polyphenol Blend on the Intestinal Inflammatory and Metabolic Responses to a High Fat Meal in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03309982
- Acronym / sponsor ID
- 17-PHX-0002
- Conditions
- Anthocyanins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- 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.
This study will investigate the beneficial effects of supplementation with a plant polyphenol blend rich in anthocyanins on parameters of inflammation and metabolic responses following a challenge with a high-fat (HF) meal.
The investigators will use a randomized crossover study to investigate the effects of: 1) placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists of English muffin bread, sausage, egg and cheese, obtained from US market and completed with palm fat. The total energy content of the high-fat meal is 1,026 Kcal with 70.5 g of fat (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g protein with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. The high-fat meal will be standard and it will not be adjusted for large and small participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized placebo-controlled cross-over design study
| Arm | Type | Receives |
|---|---|---|
| Plant polyphenol blend | Experimental | Dietary Supplement: Plant polyphenol blendThe study product (4 g) consists of 3 g of a mix a maltodextrins, and 1 g of anthocyanin-rich plant polyphenol blend containing: 1) 100 mg bilberry extract; 2) 300 mg black currant extract; and 3) 600 mg black rice extract. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo (4 g) consists of a mix of maltodextrins (3.85 g) and Red Dye No. 40 (0.125 g) and Blue Dye No. 1 (0.025 g). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
- Males and females
- Age between 18 - 35 years inclusive
- Subjects with BMI of 22 - 29.9 kg/m2
- Subjects who agree to discontinue the use of pre- and probiotic and/or polyphenol supplements from 4 weeks prior to the first and through the last study visit
Key exclusion criteria (23 listed)
- Age < 18 or > 35 years
- BMI < 22 or > 29.9 kg/m2
- Vegetarian or other dietary restrictions that would not allow the subject to consume the highfat meal
- Regularly participates in endurance exercise activities (e.g. marathon running, triathlons)
- Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg or systolic blood pressure ≥ 160 mmHg
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 |
|---|---|---|
| Plant polyphenol blendA powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal | Dietary supplement | Plant polyphenol blend |
| PlaceboA powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal | Other | Placebo |
Primary outcome
Change from baseline in plasma endotoxin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure endotoxin in plasma
28 secondary outcomes
Change from baseline in plasma IL-6 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma insulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma GLP-1 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma GLP-2 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma GIP at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma adiponectin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma leptin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma ghrelin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma triglycerides at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total cholesterol at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma HDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma LDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma zonulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total polyphenols at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total anthocyanidins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma total catechins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in plasma glucose at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-8 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-10 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-1β at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC IL-12p70 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC TNFa at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in PBMC NF-kB at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Change from baseline in fingerstick triglycerides at 15 minutes post high-fat meal consumption
Time frame: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick total cholesterol at 15 minutes post high-fat meal consumption
Time frame: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick HDL at 15 minutes post high-fat meal consumption
Time frame: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick LDL at 15 minutes post high-fat meal consumption
Time frame: Baseline, and 15 minutes post high-fat meal consumption
Change from baseline in fingerstick glucose at 15 minutes post high-fat meal consumption
Time frame: Baseline, and 15 minutes post high-fat meal consumption
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 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Patricia Oteiza, PhD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant polyphenol blend in people with Anthocyanins, run by Pharmanex 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 10 inclusion and 23 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 Apr 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?
Change from baseline in plasma endotoxin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption (time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption). 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 20 Apr 2018.