HealthyRRB3NCT03879213
Acute Berry Intake on Metabolic Control and Cognitive Function
A study testing Active breakfast in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The objectives of this study are: 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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 1 Jun 2020
- 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
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function
The objectives of this study are:
- 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
- Evaluate the effects of acute dietary raspberry on measures of vascular function.
Read the detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This multi-center clinical trial is a randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm to evaluate the effects of acute dietary red raspberry intake on cognitive function, inflammation, insulin sensitivity / glucose handling and vascular function in overweight/obese older adults after consuming a standardized challenge meal.
A planned sample size of 30 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study dietitians, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7 day run-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 2 treatment sequences. Treatment codes will be maintained by the principal investigator/study physician. All subjects will receive both treatments, once each on 2 different occasions and separated by at least 1 week. Red raspberries or placebo will be provided with a standardized meal providing 840 kcal. A low-polyphenol snack will be provided to subjects after their final cognitive assessment.
Each visit will last ~ 9.5 hours and subjects will be required to remain at the Clinical Unit for the duration of the visit. Blood samples will be collected at 0 (fasting) and at 0.5 h, 1 h, 2 h, 4 h, 5 h, 6 h and 7.5 h via a catheter placed on the non-dominant arm by a registered nurse. Cognitive function will be measured at 0 (fasting), 2 h, and 6 h. FMD or NIRS will be conducted at the CNRC or the HNRCA, respectively at 0 (fasting), and at 1 h and 5 h.
- Conditions
- Healthy
- Being tested
- Active breakfast, Control breakfast
- Keywords
- Raspberry, Metabolic responses, Endothelial function, Cognitive function
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.
Changes in Profile of Mood States response between 2 treatments
Cognitive assessment tasks will be performed in Profile of Mood States
Measured: Baseline to 6 hours
Changes in Digit Symbol Coding response between 2 treatments
Cognitive assessment tasks will be performed in Digit Symbol Coding
Measured: Baseline to 6 hours
Changes in Hopkins Verbal Learning Test response between 2 treatments
Cognitive assessment tasks will be performed in Hopkins Verbal Learning Test
Measured: Baseline to 6 hours
Changes in CANTAB- paired-associates-learning response between 2 treatments
Cognitive assessment tasks will be performed in CANTAB- paired-associates-learning
Measured: Baseline to 6 hours
Changes in CANTAB- rapid-visual-information-processing response between 2 treatments
Cognitive assessment tasks will be performed in CANTAB- rapid-visual-information-processing
Measured: Baseline to 6 hours
Changes in CANTAB- spatial-working-memory response between 2 treatments
Cognitive assessment tasks will be performed in CANTAB- spatial-working-memory
Measured: Baseline to 6 hours
Secondary outcomes (2)
Changes in Psychomotor function between 2 treatments
Psychomotor function will be measured with the Grooved Pegboard
Measured: Baseline to 6 hours
Changes in postprandial endothelial function between 2 treatments
Vascular Assessments will be measured with Flow mediated vasodilation (FMD)
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 posted18 Mar 2019
- Study start17 Sep 2018
- Primary completion1 Feb 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multi center, randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879213
- Sponsor's protocol ID
- IRB2018-046
- Acronym
- RRB3
- Status last verified
- Jul 2020
- First submitted
- 14 Mar 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. 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
- NCT03879213
- Acronym / sponsor ID
- RRB3 / IRB2018-046
- Conditions
- Healthy
- Keywords
- Raspberry, Metabolic responses, Endothelial function, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 18 Mar 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.
The objectives of this study are:
- 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
- Evaluate the effects of acute dietary raspberry on measures of vascular function.
Detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This multi-center clinical trial is a randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm to evaluate the effects of acute dietary red raspberry intake on cognitive function, inflammation, insulin sensitivity / glucose handling and vascular function in overweight/obese older adults after consuming a standardized challenge meal.
A planned sample size of 30 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study dietitians, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7 day run-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 2 treatment sequences. Treatment codes will be maintained by the principal investigator/study physician. All subjects will receive both treatments, once each on 2 different occasions and separated by at least 1 week. Red raspberries or placebo will be provided with a standardized meal providing 840 kcal. A low-polyphenol snack will be provided to subjects after their final cognitive assessment.
Each visit will last ~ 9.5 hours and subjects will be required to remain at the Clinical Unit for the duration of the visit. Blood samples will be collected at 0 (fasting) and at 0.5 h, 1 h, 2 h, 4 h, 5 h, 6 h and 7.5 h via a catheter placed on the non-dominant arm by a registered nurse. Cognitive function will be measured at 0 (fasting), 2 h, and 6 h. FMD or NIRS will be conducted at the CNRC or the HNRCA, respectively at 0 (fasting), and at 1 h and 5 h.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multi center, randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm
| 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
Changes in Profile of Mood States response between 2 treatments
Time frame: Baseline to 6 hours
Cognitive assessment tasks will be performed in Profile of Mood States
Changes in Digit Symbol Coding response between 2 treatments
Time frame: Baseline to 6 hours
Cognitive assessment tasks will be performed in Digit Symbol Coding
Changes in Hopkins Verbal Learning Test response between 2 treatments
Time frame: Baseline to 6 hours
Cognitive assessment tasks will be performed in Hopkins Verbal Learning Test
Changes in CANTAB- paired-associates-learning response between 2 treatments
Time frame: Baseline to 6 hours
Cognitive assessment tasks will be performed in CANTAB- paired-associates-learning
Changes in CANTAB- rapid-visual-information-processing response between 2 treatments
Time frame: Baseline to 6 hours
Cognitive assessment tasks will be performed in CANTAB- rapid-visual-information-processing
Changes in CANTAB- spatial-working-memory response between 2 treatments
Time frame: Baseline to 6 hours
Cognitive assessment tasks will be performed in CANTAB- spatial-working-memory
2 secondary outcomes
Changes in Psychomotor function between 2 treatments
Time frame: Baseline to 6 hours
Changes in postprandial endothelial function between 2 treatments
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 14 Jul 2020.
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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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
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 Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 14 Jul 2020. 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 in Profile of Mood States response between 2 treatments (time frame: Baseline to 6 hours). The study lists 6 primary outcomes in all. 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 14 Jul 2020.