AgingNCT03743792
Acute Raspberry Intake on Metabolic Control and Cognitive Function
A study testing Active breakfast in people with Aging and Age-related Cognitive Decline, run by USDA Human Nutrition Research Center on Aging at 1 site in United States.
Trial summary
The purpose of this project is to determine whether restoring the post-prandial metabolic/inflammatory balance via supplementation with raspberries results in improved cognitive performance, and if these enhancements are mediated through improvements in vascular function. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Age-related Cognitive Decline, Obesity
- What is being tested?
- Active breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Apr 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 27 and 35 kg/m2 and/or waist circumference (>35 inches for women, >40 inches for men)
- Aged 55-70 years old
- Able to provide informed consent and comply with study procedures
- Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
- Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
Who cannot join
- Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
- Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders
- Have recent surgery or injury to head
- Mini-Mental Status Exam score < 24 or Beck Depression Inventory score > 20
- Taking any medications that would interfere with outcomes of the study (i.e., lipid- lowering medications, anti-inflammatory drugs, and supplements, not including multivitamin/mineral or calcium/Vit D supplements),
- Unstable use of any medication/supplement
Show all 19Show fewer
- Have a history of cancer in the prior 5 years, except for non-melanoma skin cancer
- Addicted to drugs and/or alcohol (>2 drinks/day)
- Have been exposed to any non-registered drug product within last 30 days.
- Working overnight (e.g. 3rd shift of overnight workers)
- Excessive exercisers or trained athletes
- Have allergies/intolerances to berries.
- Vegetarian/vegan or have extreme dietary habits.
- Excessive coffee/tea drinker
- Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months)
- Donated blood within last 3 months
- Female who is pregnant, planning to be pregnant, breastfeeding
- Current regular consumption of berries which exceeds > 2 servings per day
- The individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function
The purpose of this project is to determine whether restoring the post-prandial metabolic/inflammatory balance via supplementation with raspberries results in improved cognitive performance, and if these enhancements are mediated through improvements in vascular function.
Read the detailed description
This study will investigate the effects of red raspberry in a relevant human model of metabolic disturbance to understand the relationship between red raspberry intake, metabolic and immune- balance and cognitive and psychomotor performance in older/over weight adults. A secondary goal of the project is to provide data on central vascular function in relation to metabolic-, inflammatory- and cognitive outcomes. Our primary working hypothesis is that red raspberries will improve metabolic- / inflammatory- balance in older overweight and obese adults resulting in improved cognitive and psychomotor performance mediated in part through improvements in vascular function. Two main objectives have been devised to meet the goals of the project and test our hypotheses: 1) Evaluate the effects of acute dietary raspberry intake on metabolic-associated impairments in cognitive and psychomotor function in overweight/obese adults (55-70y) following a meal challenge. 2) Evaluate the effects of acute dietary raspberry on measures of vascular function
- Conditions
- Aging, Age-related Cognitive Decline, Obesity
- Being tested
- Active breakfast, Control breakfast
- Keywords
- Raspberry, Cognition, Vascular function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active breakfastDietary supplement
freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich
Control breakfastDietary supplement
Control drink + buttermilk biscuit sandwich
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Freeze-dried red raspberry powder (25 g) in active breakfast meal Receives: Dietary Supplement: Active breakfast |
| Placebo | Placebo comparator | Placebo breakfast Receives: Dietary Supplement: Control breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor function
Psychomotor function will be measured with the Grooved Pegboard
Measured: Baseline to 6 hours
Secondary outcomes (1)
Endothelial function
Vascular assessments will be measured using Near-infrared spectroscopy (NIRS)
Measured: Baseline to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Oct 2021
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Human Nutrition Research Center on Aging
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Barbara Shukitt-Hale, PhD, Principal investigator, USDA Human Nutrition Research Center on AgingTammy M Scott, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743792
- Sponsor's protocol ID
- 13165
- Status last verified
- May 2023
- First submitted
- 7 Nov 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function
- ClinicalTrials.gov ID
- NCT03743792
- Acronym / sponsor ID
- 13165
- Conditions
- Aging, Age-related Cognitive Decline, Obesity
- Keywords
- Raspberry, Cognition, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- USDA Human Nutrition Research Center on AgingUS federal agency
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 16 Nov 2018 (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.
The purpose of this project is to determine whether restoring the post-prandial metabolic/inflammatory balance via supplementation with raspberries results in improved cognitive performance, and if these enhancements are mediated through improvements in vascular function.
Detailed description
This study will investigate the effects of red raspberry in a relevant human model of metabolic disturbance to understand the relationship between red raspberry intake, metabolic and immune- balance and cognitive and psychomotor performance in older/over weight adults. A secondary goal of the project is to provide data on central vascular function in relation to metabolic-, inflammatory- and cognitive outcomes. Our primary working hypothesis is that red raspberries will improve metabolic- / inflammatory- balance in older overweight and obese adults resulting in improved cognitive and psychomotor performance mediated in part through improvements in vascular function. Two main objectives have been devised to meet the goals of the project and test our hypotheses: 1) Evaluate the effects of acute dietary raspberry intake on metabolic-associated impairments in cognitive and psychomotor function in overweight/obese adults (55-70y) following a meal challenge. 2) Evaluate the effects of acute dietary raspberry on measures of vascular function
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: Active breakfastFreeze-dried red raspberry powder (25 g) in active breakfast meal |
| Placebo | Placebo comparator | Dietary Supplement: Control breakfastPlacebo breakfast |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI between 27 and 35 kg/m2 and/or waist circumference (>35 inches for women, >40 inches for men)
- Aged 55-70 years old
- Able to provide informed consent and comply with study procedures
- Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
- Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
Key exclusion criteria (19 listed)
- Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
- Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders
- Have recent surgery or injury to head
- Mini-Mental Status Exam score < 24 or Beck Depression Inventory score > 20
- Taking any medications that would interfere with outcomes of the study (i.e., lipid- lowering medications, anti-inflammatory drugs, and supplements, not including multivitamin/mineral or calcium/Vit D supplements),
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 |
|---|---|---|
| Active breakfastfreeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich | Dietary supplement | Active |
| Control breakfastControl drink + buttermilk biscuit sandwich | Dietary supplement | Placebo |
Primary outcome
Psychomotor function
Time frame: Baseline to 6 hours
Psychomotor function will be measured with the Grooved Pegboard
1 secondary outcome
Endothelial function
Time frame: Baseline to 5 hours
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 10 May 2023.
- 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.
Barbara Shukitt-Hale, PhD principal investigator
USDA Human Nutrition Research Center on Aging
Tammy M Scott, PhD principal investigator
Tufts 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 Active breakfast in people with Aging and Age-related Cognitive Decline, run by USDA Human Nutrition Research Center on Aging 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 19 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 10 May 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?
Psychomotor function (time frame: Baseline to 6 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 10 May 2023.