NCT04049162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

3.2 years

First QC Date

July 23, 2019

Last Update Submit

January 19, 2023

Conditions

Sedentary LifestyleBlood PressureArterial StiffnessOverweight and Obesity

Keywords

BlueberriesPulse Wave VelocityAgingExerciseCognition

Outcome Measures

Primary Outcomes (1)

  • 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)

    0 to 12 weeks

Secondary Outcomes (8)

  • Change from baseline in cognitive flexibility at 12 weeks

    0 to 12 weeks

  • Change from baseline in physical activity at 12 weeks

    0 to 12 weeks

  • Change from baseline in ambulatory blood Pressure at 12 weeks

    0 to 12 weeks

  • Change from baseline in total calories at 4, 8 and 12 weeks

    0 to 12 weeks (0, 4, 8 and 12 weeks)

  • Change from baseline in macronutrient intake at 4, 8 and 12 weeks

    0 to 12 weeks (0, 4, 8 and 12 weeks)

  • +3 more secondary outcomes

Other Outcomes (17)

  • Change from baseline in central arterial pressure at 12 weeks

    0 to 12 weeks

  • Baseline dietary intake (Total calories)

    0 weeks

  • Baseline dietary intake (macronutrient intake)

    0 weeks

  • +14 more other outcomes

Study Arms (2)

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)

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.

Dietary Supplement: Blueberry Placebo Plus Exercise (P-EX)

Interventions

Blueberry Plus Exercise (BB-EX)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.

Also known as: Lyophilized Blueberry Powder
Blueberry Plus Exercise (BB-EX)
Blueberry Placebo Plus Exercise (P-EX)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.

Also known as: Placebo Blueberry Powder
Blueberry Placebo Plus Exercise (P-EX)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • 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.

    PMID: 28283823BACKGROUND

  • 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.

    PMID: 26266408BACKGROUND

  • 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.

    PMID: 29882843BACKGROUND

  • 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.

    PMID: 25578927BACKGROUND

  • 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.

    PMID: 27846846BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorOverweightObesityMotor Activity

Interventions

blueberry extractExercise

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • William Kraus, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2019

First Posted

August 8, 2019

Study Start

September 20, 2019

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)