HealthyWBB2NCT02736331
Different Types of Fruits on Metabolic Function and Cognitive Performance
A study testing Treatment 1 and Treatment 2 in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
Primary objective is to assess the effect of the intake of different types of fruits on memory and attention. Secondary objective is to assess effect of intake of different types of fruits on metabolic markers, including glucose, insulin, total cholesterol and triglyceride and the pharmacokinetic profile of the… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment 1 and Treatment 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2016to 30 Jul 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Subject is male or female aged between 40 and 65 years of age
- Subject has BMI between 18.5 and 34.9 kg/m2, (inclusive) at screening visit
- Fasting blood sugar less than 126 mg/dL
- Average Blood pressure less than 160/100 mmHg
- Subject is willing to maintain a stable body weight and to follow his/her regular diet and physical activity patterns throughout the study period.
- Subject is willing to refrain from vigorous physical activity and consumption of alcoholic and/or caffeinated beverages 24 h prior to each test day
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- Subject does not smoke or has abstained from smoking for at least 2 years
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications or dietary supplements that would interfere with outcomes of the study.
Who cannot join
- • Subject currently smokes or has smoked within the past 2 years
- Subject works overnight i.e. the night shift
- Subjects who have a significant sleep disorder, a traumatic brain injury, have a learning disability or attention deficit disorder or any psychiatric or neurological disturbances
- Subject is color blind, has impaired cognitive performance on the flanker test (score <60 at screening) or has a vein access score <7
- Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compounds
- Men and women known to have/diagnosed with diabetes mellitus
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- Men and women with a fasting blood glucose concentration ≥126 mg/dL
- Average blood pressure > 160/100 mmHg during screening visit
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries
- Men and women with cancer other than non-melanoma skin cancer in previous 2 years
- Men and women who are taking medication or dietary supplements that may interfere with the study procedures or the endpoints of the study (e.g. antioxidants, anti-inflammatory medications, antidepressant medications, oral and injectable hypoglycemic medications, GI medications, antibiotics, diuretics, adrenergic blockers etc.) Subjects may choose to go off dietary supplements (requires 30 days washout)
- Men and women taking antibiotics within 5 days of study start
- Men and women who have donated blood/plasma within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months
- Substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumption (> 4 cups/day)
- Unstable body weight fluctuations of >4.5kg (9.9lbs) in the past 4 weeks
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating.
- Men and women whom investigator is uncertain about subject's capability or willingness to comply with protocol requirements
- Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.
- Men and women who do excessive exercise regularly or are athlete
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 Effect of Different Types of Fruits on Metabolic Function and Cognitive Performance
Primary objective is to assess the effect of the intake of different types of fruits on memory and attention.
Secondary objective is to assess effect of intake of different types of fruits on metabolic markers, including glucose, insulin, total cholesterol and triglyceride and the pharmacokinetic profile of the anthocyanins.
Read the detailed description
The trial is designed as a randomized 2-arm, placebo-controlled, within-subjects crossover utilizing a multiple sampling, repeated measures paradigm to investigate the effects of consumption of different types of fruits on cognitive performance and metabolic responses. This trial will test 2 treatment conditions in forty men and women who will be enrolled into the study.
Each subject will be asked to come for one screening visit, a pre-study visit, and two dinner pick-ups the day before each of the two test visits and 2 test visits. Participation in this study will last approximately four weeks.
The initial screening visit will provide the subject with the informed consent document and determine eligibility through anthropometric measurements, vital signs, fasting blood glucose test , vein assessment, color test and completion of a survey relate to general eating, health, and exercise habits. In addition, subjects will take brief tests of attention and memory to ensure capability and willingness to perform tests during subsequent research visits. Eligible subjects will be trained and instructed to record all food and beverages consumed for a 3-day period (one weekend day and two weekdays) on food record diaries. At the pre-study visit, subjects will be instructed to follow a strictly limited polyphenolic diet for 7 days prior to the study and throughout their participation time, while maintaining their usual diet pattern and physical activity. A dinner meal will be provided the day before the study visit.
At each test visit, subjects will arrive at the clinic after fasting 8 to 12 hours and in a well-hydrated state. After confirming compliance with protocol, anthropometric measurements and vital signs will be taken along with a finger prick for fasting blood glucose and a catheter placement .
Fasting baseline blood sample from a catheter will be collected after which baseline cognitive performance measures will be assessed. After completing baseline measures, subjects will receive a standard breakfast meal along with a beverage containing different fruits according to the randomization sequence. Additional blood samples will be taken at 30, 60, 120, 180, 240, 300, 360, and 480 minutes after the start of the breakfast meal. Additional cognitive tests will be performed at the 120, 240, 360, and 480 minute time points. A standardized lunch will be provided between the 360 and 480 minute time points.
Subject will come to the clinic for 2 test day visits; all procedures will be the same except for the treatment (the test or control treatment).
- Conditions
- Healthy
- Being tested
- Treatment 1, Treatment 2
- Keywords
- Cognitive performance, Metabolic control, Pharmacokinetic profile, Anthocyanins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment 1Dietary supplement
Treatment 1 Beverage
Treatment 2Dietary supplement
Treatment 2 Beverage
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 Beverage | Experimental | Treatment 1 Receives: Dietary Supplement: Treatment 1 |
| Treatment 2 Beverage | Placebo comparator | Treatment 2 Receives: Dietary Supplement: Treatment 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in memory function using the Montreal Cognitive Assessment after intake of different types of fruits
Sum all sub-scores of the Montreal Cognitive Assessment
Measured: 8 hours Postprandial Study
Secondary outcomes (4)
Changes in plasma glucose concentrations after intake of different types of fruits
plasma glucose concentrations after intake of different types of fruits
Measured: 8 hours Postprandial Study
Changes in plasma insulin concentrations after intake of different types of fruits
insulin concentrations after intake of different types of fruits
Measured: 8 hours Postprandial Study
Changes in plasma Triglycerides Concentrations after intake of different types of fruits
Plasma Triglycerides Concentrations after intake of different types of fruits
Measured: 8 hours Postprandial Study
Changes in plasma Total Cholesterol Concentrations after intake of different types of fruits
plasma Total Cholesterol Concentrations after intake of different types of fruits
Measured: 8 hours Postprandial Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start2 Mar 2016
- Primary completion30 Oct 2019
- Study completion30 Jul 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT02736331
- Sponsor's protocol ID
- IRB2015-105
- Acronym
- WBB2
- Status last verified
- Jul 2021
- First submitted
- 31 Mar 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Fruits on Metabolic Function and Cognitive Performance
- ClinicalTrials.gov ID
- NCT02736331
- Acronym / sponsor ID
- WBB2 / IRB2015-105
- Conditions
- Healthy
- Keywords
- Cognitive performance, Metabolic control, Pharmacokinetic profile, Anthocyanins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 13 Apr 2016 (estimated)
- 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.
Primary objective is to assess the effect of the intake of different types of fruits on memory and attention.
Secondary objective is to assess effect of intake of different types of fruits on metabolic markers, including glucose, insulin, total cholesterol and triglyceride and the pharmacokinetic profile of the anthocyanins.
Detailed description
The trial is designed as a randomized 2-arm, placebo-controlled, within-subjects crossover utilizing a multiple sampling, repeated measures paradigm to investigate the effects of consumption of different types of fruits on cognitive performance and metabolic responses. This trial will test 2 treatment conditions in forty men and women who will be enrolled into the study.
Each subject will be asked to come for one screening visit, a pre-study visit, and two dinner pick-ups the day before each of the two test visits and 2 test visits. Participation in this study will last approximately four weeks.
The initial screening visit will provide the subject with the informed consent document and determine eligibility through anthropometric measurements, vital signs, fasting blood glucose test , vein assessment, color test and completion of a survey relate to general eating, health, and exercise habits. In addition, subjects will take brief tests of attention and memory to ensure capability and willingness to perform tests during subsequent research visits. Eligible subjects will be trained and instructed to record all food and beverages consumed for a 3-day period (one weekend day and two weekdays) on food record diaries. At the pre-study visit, subjects will be instructed to follow a strictly limited polyphenolic diet for 7 days prior to the study and throughout their participation time, while maintaining their usual diet pattern and physical activity. A dinner meal will be provided the day before the study visit.
At each test visit, subjects will arrive at the clinic after fasting 8 to 12 hours and in a well-hydrated state. After confirming compliance with protocol, anthropometric measurements and vital signs will be taken along with a finger prick for fasting blood glucose and a catheter placement .
Fasting baseline blood sample from a catheter will be collected after which baseline cognitive performance measures will be assessed. After completing baseline measures, subjects will receive a standard breakfast meal along with a beverage containing different fruits according to the randomization sequence. Additional blood samples will be taken at 30, 60, 120, 180, 240, 300, 360, and 480 minutes after the start of the breakfast meal. Additional cognitive tests will be performed at the 120, 240, 360, and 480 minute time points. A standardized lunch will be provided between the 360 and 480 minute time points.
Subject will come to the clinic for 2 test day visits; all procedures will be the same except for the treatment (the test or control treatment).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 Beverage | Experimental | Dietary Supplement: Treatment 1Treatment 1 |
| Treatment 2 Beverage | Placebo comparator | Dietary Supplement: Treatment 2Treatment 2 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Subject is male or female aged between 40 and 65 years of age
Key exclusion criteria (20 listed)
- • Subject currently smokes or has smoked within the past 2 years
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 |
|---|---|---|
| Treatment 1Treatment 1 Beverage | Dietary supplement | Treatment 1 Beverage |
| Treatment 2Treatment 2 Beverage | Dietary supplement | Treatment 2 Beverage |
Primary outcome
Changes in memory function using the Montreal Cognitive Assessment after intake of different types of fruits
Time frame: 8 hours Postprandial Study
Sum all sub-scores of the Montreal Cognitive Assessment
4 secondary outcomes
Changes in plasma glucose concentrations after intake of different types of fruits
Time frame: 8 hours Postprandial Study
Changes in plasma insulin concentrations after intake of different types of fruits
Time frame: 8 hours Postprandial Study
Changes in plasma Triglycerides Concentrations after intake of different types of fruits
Time frame: 8 hours Postprandial Study
Changes in plasma Total Cholesterol Concentrations after intake of different types of fruits
Time frame: 8 hours Postprandial Study
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 27 Jul 2021.
- 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.
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 Treatment 1 and Treatment 2 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 9 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 27 Jul 2021. 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 memory function using the Montreal Cognitive Assessment after intake of different types of fruits (time frame: 8 hours Postprandial Study). 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 27 Jul 2021.