Sedentary LifestyleBEACTIVENCT04049162
Blueberry Enhances Activity and Cognition Through Increased Vascular Efficiency
A study testing Blueberry Plus Exercise (BB-EX) in people with Sedentary Lifestyle and Blood Pressure, run by Duke University at 1 site in United States.
Trial summary
Recent evidence suggests that increased berry intake results in a variety of health benefits, across multiple health domains. This 3-month randomized, double-blind, placebo-controlled trial assess the effects of combining daily blueberry intake with weekly exercise (BB-EX) on cardiovascular function, as well as… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Blood Pressure, Arterial Stiffness
- What is being tested?
- Blueberry Plus Exercise (BB-EX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 22 Nov 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 and older
- Overweight (BMI ≥25 to 35 kg/m2)
- Well-controlled blood pressure (< 150/90 mmHg)
- Able to speak and understand spoken and written English
- Cognitively normal (Mini-Cog score 3-5)
- Able to walk independently
- Social security number (required for compensation)
- Own a smartphone or other mobile device capable of downloading the Garmin Connect app
Who cannot join
- Exercise > 150 minutes/week
- Unwillingness or inability to be randomized to any one of two intervention groups without knowing which (double-blind), submit to all study testing, or continuously participate in a randomly assigned diet and exercise intervention for six months.
- Unwilling to restrict consumption of anthocyanin-rich foods
- Unwillingness to abstain from mood altering drugs (including marijuana but excluding CBDs) for 7 days prior to baseline and endpoint testing.
- Self-reported vegetarian or vegan.
- Inability to complete written recording forms including journals of eating and exercise behaviors.
Show all 20Show fewer
- Inability to complete written and computerized cognitive tasks (presented in English).
- Allergy or intolerance to blueberry or placebo powder ingredients Placebo ingredients include: maltodextrin, fructose, artificial blueberry flavor, natural blueberry flavor, artificial purple color (water, FD\&C Red #40, FD\&C Blue #1, malic acid, sodium benzoate) citric acid, and artificial red color (water, FD\&C Red #40, malic acid, sodium benzoate, silica dioxide).
- Gastrointestinal disorders that influence digestion and absorption of food, e.g., IBD
- History of frequent urinary tract or Clostridium difficile infections
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Regular use of medication that interferes with the measurement of study outcomes as determined by the study physician.
- Unstable use of medications, other than statins, for conditions associated with metabolic syndrome (hypertension, diabetes, dyslipidemia) during the prior 6 months or during the study.
- Antibiotic use in the last 3 months.
- Cigarette smoking, chewing, or use of nicotine replacement products in the past 3 months or during the course of the study.
- Colonoscopy in last 2 months.
- History of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure effecting absorption.
- History of significant weight instability (defined as > 10 pounds weight gain or loss over one month prior to study participation).
- History of cancer treatment (other than melanoma skin cancer) and not "cancer-free" for at least 1 year.
- History of anti-hormonal therapy (eg., for breast or prostate cancer) within the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Effects of Blueberry Consumption on Vascular Function, Physical Activity, and Cognition in Sedentary Older Adults
Recent evidence suggests that increased berry intake results in a variety of health benefits, across multiple health domains. This 3-month randomized, double-blind, placebo-controlled trial assess the effects of combining daily blueberry intake with weekly exercise (BB-EX) on cardiovascular function, as well as physical activity and cognitive function, in sedentary older adults (>60 years). We will compare these effects to the same outcomes with a control group consuming a blueberry placebo (P-EX) at 0, 4, 8 and 12 weeks.
Read the detailed description
A 12-week randomized, double-blind, placebo-controlled physical activity intervention will be administered in sedentary older (>60 years) women and men randomized to either lyophilized blueberry powder, rehydrated and consumed as a beverage twice daily with meals (BB-EX; n = 25), or an indistinguishable placebo powder, taken in the same manner (placebo control; P-EX; n = 25).
Vascular function (primary outcome), 24-hr ambulatory blood pressure, cognitive performance, and related secondary measures will be assessed at 0 and 12 weeks; berry and nutrient intake and function are assessed every 4 weeks; and physical activity as step counts will be continuously monitored using a mobile device (Garmin). Blood, urine (24-hr), and stool samples will be collected at 0 and 12 weeks and archived for later analysis.
The 12-week study duration is based upon the timing of vascular responses seen in other trials, as well as the minimal time needed to expect a change in cognitive performance in an older adult population. The blueberry dose of 36 grams per day in a split dose consumed with meals is based on (1) a 33% increase in dose over that previously used in a longer (6-month) trial; (2) delivering the most effective dose of blueberry bioactives; and (3) reduced likelihood of any gastrointestinal symptoms.
- Being tested
- Blueberry Plus Exercise (BB-EX), Blueberry Placebo Plus Exercise (P-EX)
- Keywords
- Blueberries, Pulse Wave Velocity, Aging, Exercise, Cognition
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry Plus Exercise (BB-EX)Dietary supplement
Also called Lyophilized Blueberry Powder
Pre-packaged blueberry powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention.
Blueberry Placebo Plus Exercise (P-EX)Dietary supplement
Also called Placebo Blueberry Powder
Pre-packaged placebo powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Plus Exercise (BB-EX) | Experimental | BB-Ex participants will consume lyophilized blueberry powder, mixed with water (18 grams, equivalent to 3/4ths cup of blueberries) with 2 daily meals (36 g/d blueberry powder total; approx. 1.5 servings/d) Receives: Dietary Supplement: Blueberry Plus Exercise (BB-EX) |
| Blueberry Placebo Plus Exercise (P-EX) | Placebo comparator | Participants randomized to P-EX treatment will consume an indistinguishable placebo powder, matched for color, flavor, consistency, and caloric content, in the same manner. Receives: Dietary Supplement: Blueberry Placebo Plus Exercise (P-EX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pulse wave velocity at 12 weeks
Change in carotid-femoral pulse wave velocity will be assessed using applanation tonometry, (SphygmoCor Pulse Wave Velocity System)
Measured: 0 to 12 weeks
Secondary outcomes (8)
Change from baseline in cognitive flexibility at 12 weeks
Change in cognitive performance will be assessed using a computerized task-switching test in which participants predictably alternate between two discrimination tasks.
Measured: 0 to 12 weeks
Change from baseline in physical activity at 12 weeks
Change in physical activity will be measured using a commercial activity monitor, which will be worn 24 hr/d to capture total daily steps as the measure of physical activity.
Measured: 0 to 12 weeks
Change from baseline in ambulatory blood Pressure at 12 weeks
Change in ambulatory blood pressure will be measured using an Ambulatory BP Monitor, with readings taken every 30 min. during the day and 60 min. at night, over a 24-hour period.
Measured: 0 to 12 weeks
Change from baseline in total calories at 4, 8 and 12 weeks
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Measured: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline in macronutrient intake at 4, 8 and 12 weeks
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Measured: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline in micronutrient intake at 4, 8 and 12 weeks
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Measured: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline aerobic endurance at 4, 8, and 12 weeks
Change in aerobic endurance will be determined by a 6-minute walk where subjects walk as many laps as possible in 6 minutes between cones placed 100 feet apart.
Measured: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline hand grip strength at 4, 8 and 12 weeks
Change in maximal upper body strength will be determined using hydraulic isometric hand dynamometer.
Measured: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start20 Sep 2019
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Sponsor
- Investigators
- William Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049162
- Sponsor's protocol ID
- Pro00101714
- Acronym
- BEACTIVE
- Status last verified
- Jan 2023
- First submitted
- 23 Jul 2019
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller MG, Hamilton DA, Joseph JA, Shukitt-Hale B. Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2018 Apr;57(3):1169-1180. doi: 10.1007/s00394-017-1400-8. Epub 2017 Mar 10.
PubMed 28283823Michalska A, Lysiak G. Bioactive Compounds of Blueberries: Post-Harvest Factors Influencing the Nutritional Value of Products. Int J Mol Sci. 2015 Aug 10;16(8):18642-63. doi: 10.3390/ijms160818642.
PubMed 26266408Whyte AR, Cheng N, Fromentin E, Williams CM. A Randomized, Double-Blinded, Placebo-Controlled Study to Compare the Safety and Efficacy of Low Dose Enhanced Wild Blueberry Powder and Wild Blueberry Extract (ThinkBlue) in Maintenance of Episodic and Working Memory in Older Adults. Nutrients. 2018 May 23;10(6):660. doi: 10.3390/nu10060660.
PubMed 29882843Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.
PubMed 25578927Reis JF, Monteiro VV, de Souza Gomes R, do Carmo MM, da Costa GV, Ribera PC, Monteiro MC. Action mechanism and cardiovascular effect of anthocyanins: a systematic review of animal and human studies. J Transl Med. 2016 Nov 15;14(1):315. doi: 10.1186/s12967-016-1076-5.
PubMed 27846846
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blueberry Consumption on Vascular Function, Physical Activity, and Cognition in Sedentary Older Adults
- ClinicalTrials.gov ID
- NCT04049162
- Acronym / sponsor ID
- BEACTIVE / Pro00101714
- Keywords
- Blueberries, Pulse Wave Velocity, Aging, Exercise, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 8 Aug 2019 (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.
Recent evidence suggests that increased berry intake results in a variety of health benefits, across multiple health domains. This 3-month randomized, double-blind, placebo-controlled trial assess the effects of combining daily blueberry intake with weekly exercise (BB-EX) on cardiovascular function, as well as physical activity and cognitive function, in sedentary older adults (>60 years). We will compare these effects to the same outcomes with a control group consuming a blueberry placebo (P-EX) at 0, 4, 8 and 12 weeks.
Detailed description
A 12-week randomized, double-blind, placebo-controlled physical activity intervention will be administered in sedentary older (>60 years) women and men randomized to either lyophilized blueberry powder, rehydrated and consumed as a beverage twice daily with meals (BB-EX; n = 25), or an indistinguishable placebo powder, taken in the same manner (placebo control; P-EX; n = 25).
Vascular function (primary outcome), 24-hr ambulatory blood pressure, cognitive performance, and related secondary measures will be assessed at 0 and 12 weeks; berry and nutrient intake and function are assessed every 4 weeks; and physical activity as step counts will be continuously monitored using a mobile device (Garmin). Blood, urine (24-hr), and stool samples will be collected at 0 and 12 weeks and archived for later analysis.
The 12-week study duration is based upon the timing of vascular responses seen in other trials, as well as the minimal time needed to expect a change in cognitive performance in an older adult population. The blueberry dose of 36 grams per day in a split dose consumed with meals is based on (1) a 33% increase in dose over that previously used in a longer (6-month) trial; (2) delivering the most effective dose of blueberry bioactives; and (3) reduced likelihood of any gastrointestinal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Plus Exercise (BB-EX) | Experimental | Dietary Supplement: Blueberry Plus Exercise (BB-EX)BB-Ex participants will consume lyophilized blueberry powder, mixed with water (18 grams, equivalent to 3/4ths cup of blueberries) with 2 daily meals (36 g/d blueberry powder total; approx. 1.5 servings/d) |
| Blueberry Placebo Plus Exercise (P-EX) | Placebo comparator | Dietary Supplement: Blueberry Placebo Plus Exercise (P-EX)Participants randomized to P-EX treatment will consume an indistinguishable placebo powder, matched for color, flavor, consistency, and caloric content, in the same manner. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60 and older
- Overweight (BMI ≥25 to 35 kg/m2)
- Well-controlled blood pressure (< 150/90 mmHg)
- Able to speak and understand spoken and written English
- Cognitively normal (Mini-Cog score 3-5)
Key exclusion criteria (20 listed)
- Exercise > 150 minutes/week
- Unwillingness or inability to be randomized to any one of two intervention groups without knowing which (double-blind), submit to all study testing, or continuously participate in a randomly assigned diet and exercise intervention for six months.
- Unwilling to restrict consumption of anthocyanin-rich foods
- Unwillingness to abstain from mood altering drugs (including marijuana but excluding CBDs) for 7 days prior to baseline and endpoint testing.
- Self-reported vegetarian or vegan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry Plus Exercise (BB-EX)Also: Lyophilized Blueberry PowderPre-packaged blueberry powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention. | Dietary supplement | Blueberry Plus Exercise (BB-EX) |
| Blueberry Placebo Plus Exercise (P-EX)Also: Placebo Blueberry PowderPre-packaged placebo powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention. | Dietary supplement | Blueberry Placebo Plus Exercise (P-EX) |
Primary outcome
Change from baseline in pulse wave velocity at 12 weeks
Time frame: 0 to 12 weeks
Change in carotid-femoral pulse wave velocity will be assessed using applanation tonometry, (SphygmoCor Pulse Wave Velocity System)
8 secondary outcomes
Change from baseline in cognitive flexibility at 12 weeks
Time frame: 0 to 12 weeks
Change from baseline in physical activity at 12 weeks
Time frame: 0 to 12 weeks
Change from baseline in ambulatory blood Pressure at 12 weeks
Time frame: 0 to 12 weeks
Change from baseline in total calories at 4, 8 and 12 weeks
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline in macronutrient intake at 4, 8 and 12 weeks
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline in micronutrient intake at 4, 8 and 12 weeks
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline aerobic endurance at 4, 8, and 12 weeks
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline hand grip strength at 4, 8 and 12 weeks
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
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 Jan 2023.
- Background: PubMed 28283823Miller MG, Hamilton DA, Joseph JA, Shukitt-Hale B. Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2018 Apr;57(3):1169-1180. doi: 10.1007/s00394-017-1400-8. Epub 2017 Mar 10.
- Background: PubMed 26266408Michalska A, Lysiak G. Bioactive Compounds of Blueberries: Post-Harvest Factors Influencing the Nutritional Value of Products. Int J Mol Sci. 2015 Aug 10;16(8):18642-63. doi: 10.3390/ijms160818642.
- Background: PubMed 29882843Whyte AR, Cheng N, Fromentin E, Williams CM. A Randomized, Double-Blinded, Placebo-Controlled Study to Compare the Safety and Efficacy of Low Dose Enhanced Wild Blueberry Powder and Wild Blueberry Extract (ThinkBlue) in Maintenance of Episodic and Working Memory in Older Adults. Nutrients. 2018 May 23;10(6):660. doi: 10.3390/nu10060660.
- Background: PubMed 25578927Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.
- Background: PubMed 27846846Reis JF, Monteiro VV, de Souza Gomes R, do Carmo MM, da Costa GV, Ribera PC, Monteiro MC. Action mechanism and cardiovascular effect of anthocyanins: a systematic review of animal and human studies. J Transl Med. 2016 Nov 15;14(1):315. doi: 10.1186/s12967-016-1076-5.
- Duke University School of MedicineLink provided by the sponsor.
- U.S. Highbush Blueberry CouncilLink provided by the sponsor.
- 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.
William Kraus, MD principal investigator
Duke 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 Blueberry Plus Exercise (BB-EX) in people with Sedentary Lifestyle and Blood Pressure, run by Duke 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 8 inclusion and 20 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 Jan 2023. 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 pulse wave velocity at 12 weeks (time frame: 0 to 12 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 NCT04049162, which also lists 5 linked publications.
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 Jan 2023.