A Decentralized Study on Dietary Influences on Cognitive Functions

March 24, 2023 updated by: Jeroen Schmitt, Singapore Institute for Clinical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117609
        • Singapore Institute for Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Low-GI snack, administered at 10.00 and 16.00 during the test days
Other: Intervention

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.
Active Comparator: Control
Normal GI snack, administered at 10.00 and 16.00 during the test days
Other: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 test days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Cognitive ability
Time Frame: 6 test days
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.
6 test days
Subjective Alertness
Time Frame: 6 test days
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.
6 test days
Subjective Mood
Time Frame: 6 test days
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.
6 test days
Subjective Appetite
Time Frame: 6 test days
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.
6 test days
Blood Glucose
Time Frame: 11 days
Blood glucose is measured continuously through Freestyle Libre CGM (Continuous Glucose Monitor) for 11 days
11 days
Speed of processing
Time Frame: 6 test days
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.
6 test days
Sustained attention
Time Frame: 6 Test days
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).
6 Test days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBA1c
Time Frame: Day 0, Prior the actual test
HbA1c test is a simple blood test that measures your average blood sugar levels over the past 3 months. It's one of the most commonly used tests to diagnose prediabetes and diabetes. HbA1c is measured in two units of measurement: mmol/mol and percent (percentage of total hemoglobin)
Day 0, Prior the actual test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore Institute for Clinical Sciences

Investigators

  • Principal Investigator: Jeroen Schmitt, PhD, Senior Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Actual)

February 17, 2023

Study Completion (Actual)

February 17, 2023

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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