Blueberry Enhances Activity and Cognition Through Increased Vascular Efficiency

NCT ID: NCT04049162

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2022-11-22

Brief 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 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.

Conditions

Sedentary Lifestyle; Blood Pressure; Arterial Stiffness; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Blueberry Plus Exercise (BB-EX)

Intervention Type: DIETARY_SUPPLEMENT

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)

Participants randomized to P-EX treatment will consume an indistinguishable placebo powder, matched for color, flavor, consistency, and caloric content, in the same manner.

Group Type: PLACEBO_COMPARATOR

Blueberry Placebo Plus Exercise (P-EX)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Blueberry Plus Exercise (BB-EX)

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.

Intervention Type: DIETARY_SUPPLEMENT

Blueberry Placebo Plus Exercise (P-EX)

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lyophilized Blueberry Powder; Placebo Blueberry Powder

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Highbush Blueberry Council

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Kraus, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28283823 (View on PubMed)

Michalska 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.

Reference Type: BACKGROUND

PMID: 26266408 (View on PubMed)

Whyte 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.

Reference Type: BACKGROUND

PMID: 29882843 (View on PubMed)

Johnson 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.

Reference Type: BACKGROUND

PMID: 25578927 (View on PubMed)

Reis 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.

Reference Type: BACKGROUND

PMID: 27846846 (View on PubMed)

Related Links

http://medschool.duke.edu/

Duke University School of Medicine

http://www.blueberrycouncil.org

U.S. Highbush Blueberry Council

Other Identifiers

Pro00101714

Identifier Type: -

Identifier Source: org_study_id