Glucose MetabolismNCT05801731
A Decentralized Study on Dietary Influences on Cognitive Functions
A study testing Intervention in people with Glucose Metabolism and Cognitive Function, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial summary
The current study aims to investigate the cognitive effects of diet-induced blood glucose fluctuations on cognitive performance in healthy older adults over multiple days, taking advantage of the currently available techniques to continuously measure blood glucose levels and to assess cognitive performance in a… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism, Cognitive Function
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Nov 2022to 17 Feb 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 - 65 years
- Own and use a smartphone that is capable to run the study applications (Android 4.4 or later, OS 12.0 or later)
- Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
- Sufficient vision and hearing to complete study procedures based on medical judgment
- Willing and able to participate and to give written consent to comply with study procedures
Who cannot join
- Presence or history of a metabolic, neurological, or psychiatric disease
- Use of prescription or OTC medication that may influence gastrointestinal, metabolic or neurological functioning
- Any health, functional or lifestyle factor that in the judgement of the investigator may interfere with the ability to comply with study procedures and/or the generation of valid study data
- Known food allergies
- Use of illicit drugs
- Alcohol intake >1 units/day • BMI <18.5 or >30 kg/m²
- Are a member of the research team or their immediate family members. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to investigate the cognitive effects of diet-induced blood glucose fluctuations on cognitive performance in healthy older adults over multiple days, taking advantage of the currently available techniques to continuously measure blood glucose levels and to assess cognitive performance in a real-life setting.
In this fully decentralized study, subjects will undergo two times a three-day measurement period, where their blood glucose will be continuously measured by a minimally invasive sensor and where the cognitive performance is measured at multiple time points throughout a day using a short test battery administered on their mobile phone. In addition to receiving standardized breakfast and lunch meals, the subjects are administered a low-GI(Glycemic Index) or normal-GI(Glycemic Index) snack in the morning and afternoon.
Read the detailed description
The study has two main scientific objectives. First, the investigators aim to investigate the acute effect of a low versus high-GI snack taken mid-morning or mid-afternoon on cognition, appetite, alertness and mood. To this end the investigators will compare the pre-snack and ~2-hour snack measurements of the two snacks. The investigators hypothesize that the low-GI(Glycemic Index) snack, due to a blunted and sustained PPGR, leads to better cognition, appetite and alertness ratings. Secondly, the investigators aim to explore how daily fluctuations in blood glucose are associated with cognition, mood, appetite and alertness in healthy older adults. To this end the investigators will conduct exploratory correlational analyses between blood glucose parameters, the behavioural outcomes, and subject characteristics.
- Conditions
- Glucose Metabolism, Cognitive Function
- Being tested
- Intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
The low GI snack is a biscuit with a Glycemic Index of 23.8 ± 3.3. The low GI snack contains plain flour, fibre, plant-based protein, vegetable oil and a low GI sweetener.
The interventional snacks (control, experimental) are matched for caloric content.
ControlOther
The normal GI snack is a biscuit with a Glycemic Index of 54.4 ± 6.3. The control snack is formulated using basic ingredients for a biscuit recipe consisting of all-purpose flour, butter, sugar, vanilla flavour, baking soda, egg and salt.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Low-GI snack, administered at 10.00 and 16.00 during the test days Receives: Other: Intervention |
| Control | Active comparator | Normal GI snack, administered at 10.00 and 16.00 during the test days Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial working Memory
Spatial working memory is measured using Dot Memory Task. During the task, participants are presented with a set of dots on a mobile screen for a brief period of time. Following a short delay, a second set of dots is presented, and participants are asked to determine whether any of the dots in the second set were also present in the first set. Participants respond by pressing a button to indicate whether the second set of dots was a match or a non-match to the first set. The task typically involves varying the number of dots in each set to determine the participant's working memory capacity. The primary outcomes are accuracy(%) and reaction speed in milliseconds.
Measured: 6 test days
Secondary outcomes (7)
Subjective Cognitive ability
On a Visual Analog Scale that ranges from 0 to 100, where 0 represents "Not at all" and 100 indicates "Very Much," the answer to the question regarding one's cognitive ability, "'I am feeling mentally sharp," is obtained.
Measured: 6 test days
Subjective Alertness
On a Visual Analog Scale that ranges from 0 to 100, where 0 represents "Not at all" and 100 indicates "Very Much," the answer to the question regarding one's alertness, "I am feeling tired," is obtained.
Measured: 6 test days
Subjective Mood
On a Visual Analog Scale that ranges from 0 to 100, where 0 represents "Not at all" and 100 indicates "Very Much," the answer to the question regarding one's mood, "I am feeling relaxed," is obtained.
Measured: 6 test days
Subjective Appetite
On a Visual Analog Scale that ranges from 0 to 100, where 0 represents "Not at all" and 100 indicates "Very Much," the answer to the question regarding one's appetite, "I am feeling hungry," is obtained.
Measured: 6 test days
Blood Glucose
Blood glucose is measured continuously through Freestyle Libre CGM (Continuous Glucose Monitor) for 11 days
Measured: 11 days
Speed of processing
The speed of processing is measured using the Symbol Search Task. The task involves presenting participants with pairs of symbols on a screen and requiring them to match these pairs with other pairs displayed at the top of the screen. Two pairs of symbols are presented at the bottom of the screen, and participants are asked to quickly determine which of the two pairs matches the pairs displayed at the top of the screen. The task measures the median reaction time (in milliseconds) of correctly matched symbol pairs. Participants are given a brief interval of 200 milliseconds between each response and the following stimulus to complete the task. This task is used to assess how quickly individuals can process visual information and make accurate decisions.
Measured: 6 test days
Sustained attention
Sustained attention is measured using a 3-min Psychomotor Vigilance Task (PVT). The outcome variables are the median reaction time (ms) of valid responses and the number of lapses (reaction time exceeding 500ms).
Measured: 6 Test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start2 Nov 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glucose MetabolismStudies 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
- The study will be carried out according to a decentralized, randomized, placebo controlled, double-blind, cross-over design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen Schmitt, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Jeroen Schmitt, PhD, Principal investigator, Senior Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801731
- Sponsor's protocol ID
- 2022-059
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez-Bueno C, Martinez-Vizcaino V, Lopez EJ, Visier-Alfonso ME, Redondo-Tebar A, Cavero-Redondo I. Comparative Effect of Low-Glycemic Index versus High-Glycemic Index Breakfasts on Cognitive Function: A Systematic Review and Meta-Analysis. Nutrients. 2019 Jul 24;11(8):1706. doi: 10.3390/nu11081706.
PubMed 31344892Philippou E, Constantinou M. The influence of glycemic index on cognitive functioning: a systematic review of the evidence. Adv Nutr. 2014 Mar 1;5(2):119-30. doi: 10.3945/an.113.004960.
PubMed 24618754Mohapatra L, Cabral R, Bhatnagar M, Chan PW, Ng M, Chua XY, Soon CS, Massar S, de Iorio M, Schmitt JAJ. Glucoregulatory status modulates acute cognitive effects of repeated low-glycaemic snack consumption in older adults: a decentralized randomized controlled trial. Eur J Nutr. 2025 May 26;64(5):189. doi: 10.1007/s00394-025-03712-y.
PubMed 40419805
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized Study on Dietary Influences on Cognitive Functions
- ClinicalTrials.gov ID
- NCT05801731
- Acronym / sponsor ID
- 2022-059
- Conditions
- Glucose Metabolism, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 6 Apr 2023 (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 current study aims to investigate the cognitive effects of diet-induced blood glucose fluctuations on cognitive performance in healthy older adults over multiple days, taking advantage of the currently available techniques to continuously measure blood glucose levels and to assess cognitive performance in a real-life setting.
In this fully decentralized study, subjects will undergo two times a three-day measurement period, where their blood glucose will be continuously measured by a minimally invasive sensor and where the cognitive performance is measured at multiple time points throughout a day using a short test battery administered on their mobile phone. In addition to receiving standardized breakfast and lunch meals, the subjects are administered a low-GI(Glycemic Index) or normal-GI(Glycemic Index) snack in the morning and afternoon.
Detailed description
The study has two main scientific objectives. First, the investigators aim to investigate the acute effect of a low versus high-GI snack taken mid-morning or mid-afternoon on cognition, appetite, alertness and mood. To this end the investigators will compare the pre-snack and ~2-hour snack measurements of the two snacks. The investigators hypothesize that the low-GI(Glycemic Index) snack, due to a blunted and sustained PPGR, leads to better cognition, appetite and alertness ratings. Secondly, the investigators aim to explore how daily fluctuations in blood glucose are associated with cognition, mood, appetite and alertness in healthy older adults. To this end the investigators will conduct exploratory correlational analyses between blood glucose parameters, the behavioural outcomes, and subject characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will be carried out according to a decentralized, randomized, placebo controlled, double-blind, cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: InterventionLow-GI snack, administered at 10.00 and 16.00 during the test days |
| Control | Active comparator | Other: ControlNormal GI snack, administered at 10.00 and 16.00 during the test days |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 50 - 65 years
- Own and use a smartphone that is capable to run the study applications (Android 4.4 or later, OS 12.0 or later)
- Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
- Sufficient vision and hearing to complete study procedures based on medical judgment
- Willing and able to participate and to give written consent to comply with study procedures
Key exclusion criteria (7 listed)
- Presence or history of a metabolic, neurological, or psychiatric disease
- Use of prescription or OTC medication that may influence gastrointestinal, metabolic or neurological functioning
- Any health, functional or lifestyle factor that in the judgement of the investigator may interfere with the ability to comply with study procedures and/or the generation of valid study data
- Known food allergies
- Use of illicit drugs
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 |
|---|---|---|
| InterventionThe low GI snack is a biscuit with a Glycemic Index of 23.8 ± 3.3. The low GI snack contains plain flour, fibre, plant-based protein, vegetable oil and a low GI sweetener. The interventional snacks (control, experimental) are matched for caloric content. | Other | Experimental |
| ControlThe normal GI snack is a biscuit with a Glycemic Index of 54.4 ± 6.3. The control snack is formulated using basic ingredients for a biscuit recipe consisting of all-purpose flour, butter, sugar, vanilla flavour, baking soda, egg and salt. | Other | Control |
Primary outcome
Spatial working Memory
Time frame: 6 test days
Spatial working memory is measured using Dot Memory Task. During the task, participants are presented with a set of dots on a mobile screen for a brief period of time. Following a short delay, a second set of dots is presented, and participants are asked to determine whether any of the dots in the second set were also present in the first set. Participants respond by pressing a button to indicate whether the second set of dots was a match or a non-match to the first set. The task typically involves varying the number of dots in each set to determine the participant's working memory capacity. The primary outcomes are accuracy(%) and reaction speed in milliseconds.
7 secondary outcomes
Subjective Cognitive ability
Time frame: 6 test days
Subjective Alertness
Time frame: 6 test days
Subjective Mood
Time frame: 6 test days
Subjective Appetite
Time frame: 6 test days
Blood Glucose
Time frame: 11 days
Speed of processing
Time frame: 6 test days
Sustained attention
Time frame: 6 Test days
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 6 Apr 2023.
- Background: PubMed 31344892Alvarez-Bueno C, Martinez-Vizcaino V, Lopez EJ, Visier-Alfonso ME, Redondo-Tebar A, Cavero-Redondo I. Comparative Effect of Low-Glycemic Index versus High-Glycemic Index Breakfasts on Cognitive Function: A Systematic Review and Meta-Analysis. Nutrients. 2019 Jul 24;11(8):1706. doi: 10.3390/nu11081706.
- Background: PubMed 24618754Philippou E, Constantinou M. The influence of glycemic index on cognitive functioning: a systematic review of the evidence. Adv Nutr. 2014 Mar 1;5(2):119-30. doi: 10.3945/an.113.004960.
- Derived from this study: PubMed 40419805Mohapatra L, Cabral R, Bhatnagar M, Chan PW, Ng M, Chua XY, Soon CS, Massar S, de Iorio M, Schmitt JAJ. Glucoregulatory status modulates acute cognitive effects of repeated low-glycaemic snack consumption in older adults: a decentralized randomized controlled trial. Eur J Nutr. 2025 May 26;64(5):189. doi: 10.1007/s00394-025-03712-y.
- 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.
Jeroen Schmitt, PhD principal investigator
Senior Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Glucose Metabolism and Cognitive Function, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
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 7 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 6 Apr 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 Singapore. 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. 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?
Spatial working Memory (time frame: 6 test days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801731, which also lists 3 linked publications.
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 6 Apr 2023.