AnthocyaninsNCT04637945
Inflammatory and Metabolic Responses to Long-term Dietary Supplementation With Anthocyanin-rich Blend
A study testing ACRB in people with Anthocyanins, run by Pharmanex at 1 site in United States.
Trial summary
This study will investigate the capacity of an anthocyanin-rich blend (ACRB) dietary supplement to improve the alterations in lipid and glucose homeostasis triggered by consumption of a high-fat 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?
- ACRB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to Jun 2023
- 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
- Subject is healthy and, in the opinion of the investigator, free of any medical conditions that might affect study measurements.
- Male or female.
- Age between 18 - 40 years inclusive.
- BMI between 21 - 29.9 kg/m2.
- Female subject of childbearing potential has a negative urine pregnancy test result and agrees to use a medically approved method of birth control. Acceptable methods of birth control include: hormonal contraceptives such as oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System); double-barrier methods; non-hormonal intrauterine devices; vasectomy of partner; and non-heterosexual lifestyles.
- Subject agrees to discontinue the use of pre- and/or probiotic and/or polyphenol supplements from 30 days prior to the screening visit and throughout the study.
Show all 12Show fewer
- Subject agrees to consume less than 1/2 cup/day of foods containing anthocyanins (such as blueberries, blackberries, bilberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries) and no more than 1 glass/day of red wine, 3 cups/day of tea or coffee, or 10 g/day of dark chocolate from 30 days prior to the screening visit and throughout the study.
- No known allergies to study products or components (bilberries, black currants, rice).
- Subject is willing and able to completely consume high-fat meal and assigned study products within 15 min.
- Subject is willing to consume a low fat/low flavonoid dinner the evening before visits 2, 3 and 5.
- Subject has received a complete COVID-19 vaccine and is at least 6 weeks post-vaccine at the screening visit as verified by shot record or similar documentation.
- Subject has given voluntary, written, informed consent to participate in the study.
Who cannot join
- Age < 18 or > 40 years.
- BMI < 21 or > 29.9 kg/m2.
- Vegan, Vegetarian, or other dietary restrictions that would not allow the subject to consume the high-fat meal.
- Current consumption of special diets (e.g. Atkins, keto, paleo, etc.).
- Current participation or enrollment in another pharmaceutical, weight-loss or nutritional clinical study within the last 30 days. Device trials are exempted.
- Regular participation in endurance exercise activities (e.g. marathon running, triathlons).
Show all 29Show fewer
- Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg and/or systolic blood pressure ≥ 160 mmHg.
- Fasting blood triglycerides > 150 mg/dL.
- Plasma amount of triglycerides accumulated in 5 h < 170 or > 700 mg/dL x 5 h after high-fat meal consumption at screening visit.
- Self-reported Type 2 Diabetes
- Fasting blood glucose < 50 mg/dL or > 100 mg/dL.
- Hemoglobin A1c levels ≥ 5.7%.
- Current smoker or use of tobacco products within the last 180 days.
- Binge drinking (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 last 60 days.
- Daily use of anti-inflammatory medications including NSAIDs and aspirin within the last 30 days.
- Use of laxative medications or other products that promote colon cleansing within the last 30 days.
- History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism within the last 30 days.
- 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 (e.g. lap band, gastric bypass, etc.).
- Diarrhea or oral antibiotic intake within the last 30 days.
- Weight change (> 5%) within the last 30 days.
- History of eating disorders such as bulimia, anorexia, or muscle dysmorphia.
- Allergy or sensitivity to the study products or components of the high-fat meal.
- Subject has not received a complete COVID-19 vaccine or is less than 6 weeks post-vaccine at the screening visit.
- Any other condition which in the Investigator's opinion might adversely affect the subject's ability to complete the study or its measurements or which might 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 Study Investigating the Effects of a Long-term Dietary Supplementation With an Anthocyanin-rich Blend on the Metabolic and Inflammatory Responses to a High-fat Meal in Healthy Subjects
This study will investigate the capacity of an anthocyanin-rich blend (ACRB) dietary supplement to improve the alterations in lipid and glucose homeostasis triggered by consumption of a high-fat meal. Given the impact of Western style diets and obesity on the development of type 2 diabetes, cardiovascular disease and other pathologies, this study has major public health implications.
Read the detailed description
In particular, this study will investigate the beneficial effects of long-term (8 weeks) supplementation with ACRB on fasting and postprandial levels of plasma triglycerides, as well as other parameters of lipid and glucose homeostasis and inflammation. Postprandial changes will be evaluated after consumption of a high-fat meal.
Subjects will receive either a: i) placebo (control),or ii) ACRB product for 8 weeks. At the beginning and at the end of the 8-week period, subjects will be submitted to a metabolic challenge consisting of consuming a high-fat meal after receiving the study product (placebo, ACRB). The high-fat meal will consist of English muffin bread, sausage, egg and cheese, obtained from US market with carotenoid-free palm oil added to bring the total dietary fat to the desired level. The total weight of the high-fat meal will be 320 g 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. The total energy content of the high-fat meal will be 1,026 Kcal with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. Blood will be taken by venipuncture before (baseline, 0 h) and 0.25, 0.5, 1, 2, 3 and 5 h after consumption of both the high-fat meal and the study product. Plasma will be collected and chylomicrons and peripheral blood monocytes (PBMCs) will be isolated. Blood pressure and skin carotenoid content will be measured. Subjects will be also asked to collect feces before starting and at the end of the 8 week period.
- Conditions
- Anthocyanins
- Being tested
- ACRB, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRBDietary supplement
Product will be consumed once daily, preferably with breakfast.
PlaceboOther
Product will be consumed once daily, preferably with breakfast.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The placebo will be delivered in softgels consisting of colorant, olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, glycerin and water. Receives: Other: Placebo |
| ACRB | Experimental | The ACRB product will be delivered in softgels consisting of anthocyanin-rich blend. Each softgel will contain: i) 49 mg bilberry extract; ii) 101 mg black currant extract; and iii) 303 mg black rice extract. The high ACRB will deliver at least 108 mg anthocyanins. The product will also contain olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, and water. Receives: Dietary Supplement: ACRB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plasma triglycerides at week 8, both at fasting and 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, 8 weeks
Secondary outcomes (18)
Change from baseline in plasma free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure plasma free fatty acids in plasma
Measured: Baseline, 8 weeks
Change from baseline in total free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total free fatty acids in plasma
Measured: Baseline, 8 weeks
Change from baseline in HDL at week 8, both at fasting and 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, 8 weeks
Change from baseline in LDL at week 8, both at fasting and 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, 8 weeks
Change from baseline in glucose at week 8, both at fasting and at week 8, both at fasting and at 0.25hr, 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, 8 weeks
Change from baseline in insulin at week 8, both at fasting and 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, 8 weeks
Change from baseline in LPS at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure LPS in plasma
Measured: Baseline, 8 weeks
Change from baseline in LPS binding protein at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure LPS binding protein in plasma
Measured: Baseline, 8 weeks
Change from baseline in insulin resistance at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure insulin resistance in PBMCs
Measured: Baseline, 8 weeks
Change from baseline in PBMC gene expression at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to isolate RNA and measure gene expression in PBMCs. The most significantly differentially expressed transcripts will be chosen for further analysis.
Measured: Baseline, 8 weeks
Change from baseline in plasma total polyphenols at week 8, both at fasting and 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, 8 weeks
Change from baseline in plasma total anthocyanidins at week 8, both at fasting and 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, 8 weeks
Change from baseline in plasma Irisin at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure Irisin in plasma
Measured: Baseline, 8 weeks
Change from baseline in total blood gene expression at week 8, both at fasting and at 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to isolate RNA and measure gene expression in whole blood. The most significantly deferentially expressed transcripts will be chosen for further analysis.
Measured: Baseline, 8 weeks
Change from baseline in blood pressure at week 8, both at fasting and at 1hrs, 2hrs, 3hrs, 4hrs, and 5hrs post high-fat meal consumption
blood pressure measured by sphygmomanometer
Measured: Baseline, 8 weeks
Change from baseline in fecal microbiota composition at week 8
stool sample collected to measure gut microbiota composition using 16S rRNA gene sequences
Measured: Baseline, 8 weeks
Change from baseline in fecal short chain fatty acids at week 8
stool sample collected to measure fecal short chain fatty acids
Measured: Baseline, 8 weeks
Change from baseline in skin carotenoids at week 4, and week 8
skin carotenoid scanner will be used to produce a raman score of skin carotenoids
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jul 2021
- Primary completion1 Dec 2022
- Study completionJun 2023 (estimated)
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Oteiza, PhD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637945
- Sponsor's protocol ID
- 20-PHX-0002
- Status last verified
- Dec 2022
- First submitted
- 5 Aug 2020
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized Placebo-controlled Study Investigating the Effects of a Long-term Dietary Supplementation With an Anthocyanin-rich Blend on the Metabolic and Inflammatory Responses to a High-fat Meal in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04637945
- Acronym / sponsor ID
- 20-PHX-0002
- Conditions
- Anthocyanins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Nov 2020 (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 capacity of an anthocyanin-rich blend (ACRB) dietary supplement to improve the alterations in lipid and glucose homeostasis triggered by consumption of a high-fat meal. Given the impact of Western style diets and obesity on the development of type 2 diabetes, cardiovascular disease and other pathologies, this study has major public health implications.
Detailed description
In particular, this study will investigate the beneficial effects of long-term (8 weeks) supplementation with ACRB on fasting and postprandial levels of plasma triglycerides, as well as other parameters of lipid and glucose homeostasis and inflammation. Postprandial changes will be evaluated after consumption of a high-fat meal.
Subjects will receive either a: i) placebo (control),or ii) ACRB product for 8 weeks. At the beginning and at the end of the 8-week period, subjects will be submitted to a metabolic challenge consisting of consuming a high-fat meal after receiving the study product (placebo, ACRB). The high-fat meal will consist of English muffin bread, sausage, egg and cheese, obtained from US market with carotenoid-free palm oil added to bring the total dietary fat to the desired level. The total weight of the high-fat meal will be 320 g 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. The total energy content of the high-fat meal will be 1,026 Kcal with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. Blood will be taken by venipuncture before (baseline, 0 h) and 0.25, 0.5, 1, 2, 3 and 5 h after consumption of both the high-fat meal and the study product. Plasma will be collected and chylomicrons and peripheral blood monocytes (PBMCs) will be isolated. Blood pressure and skin carotenoid content will be measured. Subjects will be also asked to collect feces before starting and at the end of the 8 week period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: PlaceboThe placebo will be delivered in softgels consisting of colorant, olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, glycerin and water. |
| ACRB | Experimental | Dietary Supplement: ACRBThe ACRB product will be delivered in softgels consisting of anthocyanin-rich blend. Each softgel will contain: i) 49 mg bilberry extract; ii) 101 mg black currant extract; and iii) 303 mg black rice extract. The high ACRB will deliver at least 108 mg anthocyanins. The product will also contain olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, and water. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject is healthy and, in the opinion of the investigator, free of any medical conditions that might affect study measurements.
- Male or female.
- Age between 18 - 40 years inclusive.
- BMI between 21 - 29.9 kg/m2.
- Female subject of childbearing potential has a negative urine pregnancy test result and agrees to use a medically approved method of birth control. Acceptable methods of birth control include: hormonal contraceptives such as oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System); double-barrier methods; non-hormonal intrauterine devices; vasectomy of partner; and non-heterosexual lifestyles.
Key exclusion criteria (29 listed)
- Age < 18 or > 40 years.
- BMI < 21 or > 29.9 kg/m2.
- Vegan, Vegetarian, or other dietary restrictions that would not allow the subject to consume the high-fat meal.
- Current consumption of special diets (e.g. Atkins, keto, paleo, etc.).
- Current participation or enrollment in another pharmaceutical, weight-loss or nutritional clinical study within the last 30 days. Device trials are exempted.
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 |
|---|---|---|
| ACRBProduct will be consumed once daily, preferably with breakfast. | Dietary supplement | ACRB |
| PlaceboProduct will be consumed once daily, preferably with breakfast. | Other | placebo |
Primary outcome
Change from baseline in plasma triglycerides at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
blood sample collected by venipuncture to measure triglycerides in plasma
18 secondary outcomes
Change from baseline in plasma free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in total free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in HDL at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in LDL at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in glucose at week 8, both at fasting and at week 8, both at fasting and at 0.25hr, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in insulin at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in LPS at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in LPS binding protein at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in insulin resistance at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in PBMC gene expression at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in plasma total polyphenols at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in plasma total anthocyanidins at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in plasma Irisin at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in total blood gene expression at week 8, both at fasting and at 3hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in blood pressure at week 8, both at fasting and at 1hrs, 2hrs, 3hrs, 4hrs, and 5hrs post high-fat meal consumption
Time frame: Baseline, 8 weeks
Change from baseline in fecal microbiota composition at week 8
Time frame: Baseline, 8 weeks
Change from baseline in fecal short chain fatty acids at week 8
Time frame: Baseline, 8 weeks
Change from baseline in skin carotenoids at week 4, and week 8
Time frame: baseline, 4 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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 ACRB 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 12 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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?
Results are not available in the source record.
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 triglycerides at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption (time frame: Baseline, 8 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 21 Dec 2022.