Overweight, Obesity and Other Hyperalimentation (E65-E68)NCT02751866
Early Intervention in Cognitive Aging
A study testing Berry fruit powder OR nutritional ketosis in people with Overweight, Obesity and Other Hyperalimentation (E65-E68), run by University of Cincinnati at 1 site in United States.
Trial summary
Nutritional intervention in overweight middle aged individuals with subjective memory complaints. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Overweight, Obesity and Other Hyperalimentation (E65-E68)
- What is being tested?
- Berry fruit powder OR nutritional ketosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight; subjective memory complaints
Who cannot join
- diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center
Cincinnati, Ohio, 45267-0559
About this study
Nutritional intervention in overweight middle aged individuals with subjective memory complaints.
Read the detailed description
Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.
- Being tested
- Berry fruit powder OR nutritional ketosis, Placebo powder OR higher carbohydrate
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry fruit powder OR nutritional ketosisDietary supplement
Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
Placebo powder OR higher carbohydrateDietary supplement
Daily supplementation with placebo powder OR higher carbohydrate intake
| Study group | Role | What they receive |
|---|---|---|
| Active supplement, low carbohydrate | Active comparator | Whole fruit berry powder, low carbohydrate diet Receives: Dietary Supplement: Berry fruit powder OR nutritional ketosis |
| Placebo, Control | Placebo comparator | placebo powder, higher carbohydrate diet Receives: Dietary Supplement: Placebo powder OR higher carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
HOMA-IR will be derived from fasting glucose and insulin
Measured: Eight or 12 weeks after enrollment
Cognitive function
Performances on examiner-adminstered instruments assessing memory function
Measured: Eight or 12 weeks after enrollment
Secondary outcomes (1)
Long term glucose concentration
Glycated hemoglobin value
Measured: Eight or 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, Obesity and Other Hyperalimentation (E65-E68)Studies 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
- Parallel groups
- Model description
- Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Krikorian, University of Cincinnati
- Investigators
- Robert Krikorian, PhD, Principal investigator, University of Cincinnati Academic Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751866
- Sponsor's protocol ID
- 2015-1256
- Status last verified
- Mar 2025
- First submitted
- 21 Apr 2016
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention in Cognitive Aging
- ClinicalTrials.gov ID
- NCT02751866
- Acronym / sponsor ID
- 2015-1256
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 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.
Nutritional intervention in overweight middle aged individuals with subjective memory complaints.
Detailed description
Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
| Arm | Type | Receives |
|---|---|---|
| Active supplement, low carbohydrate | Active comparator | Dietary Supplement: Berry fruit powder OR nutritional ketosisWhole fruit berry powder, low carbohydrate diet |
| Placebo, Control | Placebo comparator | Dietary Supplement: Placebo powder OR higher carbohydrateplacebo powder, higher carbohydrate diet |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight; subjective memory complaints
Key exclusion criteria (1 listed)
- diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
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 |
|---|---|---|
| Berry fruit powder OR nutritional ketosisDaily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis | Dietary supplement | Active supplement, low carbohydrate |
| Placebo powder OR higher carbohydrateDaily supplementation with placebo powder OR higher carbohydrate intake | Dietary supplement | Placebo, Control |
Primary outcome
Insulin resistance
Time frame: Eight or 12 weeks after enrollment
HOMA-IR will be derived from fasting glucose and insulin
Cognitive function
Time frame: Eight or 12 weeks after enrollment
Performances on examiner-adminstered instruments assessing memory function
1 secondary outcome
Long term glucose concentration
Time frame: Eight or 12 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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.
Robert Krikorian, PhD principal investigator
University of Cincinnati Academic Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry fruit powder OR nutritional ketosis in people with Overweight, Obesity and Other Hyperalimentation (E65-E68), run by University of Cincinnati 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Insulin resistance (time frame: Eight or 12 weeks after enrollment). The study lists 2 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 1 Apr 2025.