Clinical trial NCT05801731: A Decentralized Study on Dietary Influences on Cognitive Functions
Official title: A Decentralized Study on Dietary Influences on Cognitive Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism
Cognitive Function
Lead sponsor: Institute for Human Development and Potential (IHDP), Singapore
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be carried out according to a decentralized, randomized, placebo controlled, double-blind, cross-over design.
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Spatial working Memory
timeFrame: 6 test days
Secondary outcomes:
measure: Subjective Cognitive ability
timeFrame: 6 test days
measure: Subjective Alertness
timeFrame: 6 test days
measure: Subjective Mood
timeFrame: 6 test days
measure: Subjective Appetite
timeFrame: 6 test days
measure: Blood Glucose
timeFrame: 11 days
measure: Speed of processing
timeFrame: 6 test days
measure: Sustained attention
timeFrame: 6 Test days
Other outcomes:
measure: HBA1c
timeFrame: Day 0, Prior the actual test
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute for Clinical Trials
Study officials:
affiliation: Senior Principal Investigator
name: Jeroen Schmitt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Philippou 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.