Cardiovascular DiseaseNCT02227628
Absorption and Antioxidant Effects of Polyphenolics From Acai
A study testing Acai polyphenolics and Sugary Beverage in people with Cardiovascular Disease and Metabolic Syndrome, run by Texas A&M University at 1 site in United States.
Trial summary
A human clinical consumption trial will be performed in volunteers with increased risk factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4, 8, and 12 weeks and a 24 hr urine collection on… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Metabolic Syndrome, Obesity
- What is being tested?
- Acai polyphenolics and Sugary Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elevated waist circumference: ≥102cm in men and ≥ 88 cm in women
- Elevated triglycerides:≥ 150 mg/dL
- Reduced HDL-C:<40 mg/dL in men and <50 mg/dL in women
- Elevated blood pressure:≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure
- Elevated fasting glucose:≥ 100 mg/dL
Who cannot join
- History of any relevant acute cardiac event (myocardial infarction, episode of heart failure)
- Recent (within 3 months) or recurrent hospitalizations
- Drug treatment for type II diabetes
- aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of normal
- Abuse of alcohol or substance, smoking, history of seizures, or other relevant ongoing or recurrent illness, liver or renal dysfunction, pregnancy (positive urine pregnancy test) or lactation, known allergy against any of the juices, known infection with hepatitis B, C, or HIV, intake of vasoactive drugs
- Individuals participating in regular aerobic exercise training program (>30 minutes, ≥ 3 times/wk)
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University
College Station, Texas, 77845
About this study
A human clinical consumption trial will be performed in volunteers with increased risk factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4, 8, and 12 weeks and a 24 hr urine collection on each blood draw day.
Read the detailed description
- Experimental Design: Approximately 50 male and female participants between the ages of 18 and 65 years, who were at high risk for cardiovascular disease but have not had a hospitalization due to cardiovascular disease, were recruited to participate for 12 weeks in this study. All familiarization and testing were conducted at the Exercise \& Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A\&M University. Assays were conducted at the Institute of Obesity and Cancer research Laboratory at Texas A\&M University.
- Screening and familiarization Session: Participants expressing interest in the study were interviewed by phone to determine whether they were qualified to participate. The participants who were believed to meet the eligibility criteria were invited to attend an entry/familiarization session. During this session, participants completed medical and personal histories, and signed consent statements in compliance with the Human Participants Guidelines of Texas A\&M University and the American College of Sports Medicine. Participants then underwent a general physical examination to verify that they met the eligibility criteria. Participants who satisfied the criteria were familiarized to the study protocol and received a verbal and written explanation of the study protocol and design. Following baseline measurements, participants were matched based on gender, age, and BMI and were randomly assigned in a double-blind manner into control (n=25) or acai supplementation groups (n=25). Participants were given an appointment time to perform baseline assessments and three other sessions.
- Baseline assessments and dietary intervention: Prior to baseline testing, participants were recommended not to take any herbal supplements or anti-oxidant juices such as orange, pomegranate, or acai juice. Vitamin pills, supplemented sports/energy drinks and large amounts of berries were also to be avoided. In addition, spinach, tomatoes, bell peppers, onions, garlic, carrots, chocolate, yellow/orange fruits/vegetables and dark green fruits/vegetables were to be reduced to no more than one serving for 48 hours. Participants were instructed to refrain from exercise for 48 hours prior to baseline testing. During the baseline testing, participants recorded all food intake on dietary record forms for four days. Participants donated 20ml of fasting blood using venipuncture techniques of an antecubital vein in the forearm. Participants were then asked to drink one 10 oz serving of the test beverage. A second blood draw was taken two hours after ingestion. All urine output for the 24 hours leading up to the baseline testing was collected.
- Supplementation: Participants were recommended to consume two servings of the test beverage as part of their current, non-modified diet. Each serving was supplied in a 10 oz bottle, and was to be consumed both in the morning and in the evening of each day throughout the duration of the study (12 weeks). Participants in the control group consumed an equal amount of placebo juice comprised of artificially colored water containing sugar, citric acid, and a flavor that was identical to the acai beverage, but had no phytochemical-based constituents throughout the same time period. Participants were individually instructed on how to adjust their daily caloric intake to account for the calories of the beverage. All participants picked up weekly supplies of either the acai beverage or placebo at the Exercise \& Sport Nutrition Laboratory.
- Follow-up testing: Participants reported back to the lab for follow-up testing at 4, 8, and 12 weeks after the baseline testing. During each of those testing sessions, the participants completed the same full battery of tests that were completed during the initial baseline testing. Participants were asked to maintain a similar diet three days prior to each testing session in order to monitor the influence of the test beverage. Participants were given a list of preferred food groups for these three days and asked to stick to them as closely as possible.
- Body composition: During each baseline measurement and follow-up testing session, height was measured using standard anthropometry. Total body weight was measured using a Healthometer (Bridgeview, IL) self-calibrating digital scale with a precision of +/-0.02 kg. Body composition (excluding the cranium) was determined using a Dual-energy X-ray absorptiometry (DEXA, Hologic Inc, Waltham, MA, USA).
- Blood and urine collection: During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). Blood samples were obtained using standard phlebotomy procedures using standard sterile venipuncture of an antecubital vein by ESNL laboratory technicians or graduate research assistance trained in phlebotomy in compliance with guidelines established by the Texas Department of Health and Human Services.
- Conditions
- Cardiovascular Disease, Metabolic Syndrome, Obesity
- Being tested
- Acai polyphenolics, Sugary Beverage
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acai polyphenolicsDietary supplement
Acai beverage was obtained from the Sambazon (San Clemente, CA).
Sugary BeverageDietary supplement
An equal amount of placebo juice comprised of artificially colored water containing sugar (5%), citric acid (0.01% to adjust the pH 3.8), and artificial colors (FD\&C Red 40 and Blue 1, Tetra Pak, Denten, TX) that was identical to the acai beverage.
| Study group | Role | What they receive |
|---|---|---|
| Sugary Beverage | Placebo comparator | Sugary Beverage Receives: Dietary Supplement: Sugary Beverage |
| Acai beverage | Experimental | Acai Polyphenolics Receives: Dietary Supplement: Acai polyphenolics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine
During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). All urine output for the 24 hours leading up to the baseline testing was collected. Inflammatory biomarkers in the plasma (hs-C-reactive protein(mg/L), interleukin-6(pg/ml), interleukin-1beta(pg/ml), Interferon-gamma(pg/ml), and Tumor necrosis factor-alpha(pg/ml)) and in the urine (8-isoprostane(ng/mmol creatinine) were measured by enzyme immunoassay using Cayman chemical kits (Ann Arbor, MI).
Measured: baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Talcott, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227628
- Sponsor's protocol ID
- TexasAMU-IRB2010-0797F
- Other IDs
- IRB2010-0797F
- Status last verified
- Oct 2016
- First submitted
- 4 Jun 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Antioxidant Effects of Polyphenolics From Acai
- ClinicalTrials.gov ID
- NCT02227628
- Acronym / sponsor ID
- TexasAMU-IRB2010-0797F
- Conditions
- Cardiovascular Disease, Metabolic Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Aug 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.
A human clinical consumption trial will be performed in volunteers with increased risk factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4, 8, and 12 weeks and a 24 hr urine collection on each blood draw day.
Detailed description
- Experimental Design: Approximately 50 male and female participants between the ages of 18 and 65 years, who were at high risk for cardiovascular disease but have not had a hospitalization due to cardiovascular disease, were recruited to participate for 12 weeks in this study. All familiarization and testing were conducted at the Exercise \& Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A\&M University. Assays were conducted at the Institute of Obesity and Cancer research Laboratory at Texas A\&M University.
- Screening and familiarization Session: Participants expressing interest in the study were interviewed by phone to determine whether they were qualified to participate. The participants who were believed to meet the eligibility criteria were invited to attend an entry/familiarization session. During this session, participants completed medical and personal histories, and signed consent statements in compliance with the Human Participants Guidelines of Texas A\&M University and the American College of Sports Medicine. Participants then underwent a general physical examination to verify that they met the eligibility criteria. Participants who satisfied the criteria were familiarized to the study protocol and received a verbal and written explanation of the study protocol and design. Following baseline measurements, participants were matched based on gender, age, and BMI and were randomly assigned in a double-blind manner into control (n=25) or acai supplementation groups (n=25). Participants were given an appointment time to perform baseline assessments and three other sessions.
- Baseline assessments and dietary intervention: Prior to baseline testing, participants were recommended not to take any herbal supplements or anti-oxidant juices such as orange, pomegranate, or acai juice. Vitamin pills, supplemented sports/energy drinks and large amounts of berries were also to be avoided. In addition, spinach, tomatoes, bell peppers, onions, garlic, carrots, chocolate, yellow/orange fruits/vegetables and dark green fruits/vegetables were to be reduced to no more than one serving for 48 hours. Participants were instructed to refrain from exercise for 48 hours prior to baseline testing. During the baseline testing, participants recorded all food intake on dietary record forms for four days. Participants donated 20ml of fasting blood using venipuncture techniques of an antecubital vein in the forearm. Participants were then asked to drink one 10 oz serving of the test beverage. A second blood draw was taken two hours after ingestion. All urine output for the 24 hours leading up to the baseline testing was collected.
- Supplementation: Participants were recommended to consume two servings of the test beverage as part of their current, non-modified diet. Each serving was supplied in a 10 oz bottle, and was to be consumed both in the morning and in the evening of each day throughout the duration of the study (12 weeks). Participants in the control group consumed an equal amount of placebo juice comprised of artificially colored water containing sugar, citric acid, and a flavor that was identical to the acai beverage, but had no phytochemical-based constituents throughout the same time period. Participants were individually instructed on how to adjust their daily caloric intake to account for the calories of the beverage. All participants picked up weekly supplies of either the acai beverage or placebo at the Exercise \& Sport Nutrition Laboratory.
- Follow-up testing: Participants reported back to the lab for follow-up testing at 4, 8, and 12 weeks after the baseline testing. During each of those testing sessions, the participants completed the same full battery of tests that were completed during the initial baseline testing. Participants were asked to maintain a similar diet three days prior to each testing session in order to monitor the influence of the test beverage. Participants were given a list of preferred food groups for these three days and asked to stick to them as closely as possible.
- Body composition: During each baseline measurement and follow-up testing session, height was measured using standard anthropometry. Total body weight was measured using a Healthometer (Bridgeview, IL) self-calibrating digital scale with a precision of +/-0.02 kg. Body composition (excluding the cranium) was determined using a Dual-energy X-ray absorptiometry (DEXA, Hologic Inc, Waltham, MA, USA).
- Blood and urine collection: During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). Blood samples were obtained using standard phlebotomy procedures using standard sterile venipuncture of an antecubital vein by ESNL laboratory technicians or graduate research assistance trained in phlebotomy in compliance with guidelines established by the Texas Department of Health and Human Services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugary Beverage | Placebo comparator | Dietary Supplement: Sugary BeverageSugary Beverage |
| Acai beverage | Experimental | Dietary Supplement: Acai polyphenolicsAcai Polyphenolics |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elevated waist circumference: ≥102cm in men and ≥ 88 cm in women
- Elevated triglycerides:≥ 150 mg/dL
- Reduced HDL-C:<40 mg/dL in men and <50 mg/dL in women
- Elevated blood pressure:≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure
- Elevated fasting glucose:≥ 100 mg/dL
Key exclusion criteria (6 listed)
- History of any relevant acute cardiac event (myocardial infarction, episode of heart failure)
- Recent (within 3 months) or recurrent hospitalizations
- Drug treatment for type II diabetes
- aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of normal
- Abuse of alcohol or substance, smoking, history of seizures, or other relevant ongoing or recurrent illness, liver or renal dysfunction, pregnancy (positive urine pregnancy test) or lactation, known allergy against any of the juices, known infection with hepatitis B, C, or HIV, intake of vasoactive drugs
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 |
|---|---|---|
| Acai polyphenolicsAcai beverage was obtained from the Sambazon (San Clemente, CA). | Dietary supplement | Acai beverage |
| Sugary BeverageAn equal amount of placebo juice comprised of artificially colored water containing sugar (5%), citric acid (0.01% to adjust the pH 3.8), and artificial colors (FD\&C Red 40 and Blue 1, Tetra Pak, Denten, TX) that was identical to the acai beverage. | Dietary supplement | Sugary Beverage |
Primary outcome
Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine
Time frame: baseline, 24 hours
During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). All urine output for the 24 hours leading up to the baseline testing was collected. Inflammatory biomarkers in the plasma (hs-C-reactive protein(mg/L), interleukin-6(pg/ml), interleukin-1beta(pg/ml), Interferon-gamma(pg/ml), and Tumor necrosis factor-alpha(pg/ml)) and in the urine (8-isoprostane(ng/mmol creatinine) were measured by enzyme immunoassay using Cayman chemical kits (Ann Arbor, MI).
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 18 Oct 2016.
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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.
Susanne Talcott, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acai polyphenolics and Sugary Beverage in people with Cardiovascular Disease and Metabolic Syndrome, run by Texas A&M University 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 5 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 18 Oct 2016. 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?
Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine (time frame: baseline, 24 hours). 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 18 Oct 2016.