A Decentralized Study on Dietary Influences on Cognitive Functions

NCT05801731 | Completed DMC

• 1 other identifier: 2022-059
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• 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.

  6 test days

Secondary Outcomes (7)

• Subjective Cognitive ability

  6 test days

• Subjective Alertness

  6 test days

• Subjective Mood

  6 test days

• Subjective Appetite

  6 test days

• Blood Glucose

  11 days

Other Outcomes (1)

• HBA1c

  Day 0, Prior the actual test

Study Arms (2)

Experimental

EXPERIMENTAL

Low-GI snack, administered at 10.00 and 16.00 during the test days

Other: Intervention

Control

ACTIVE COMPARATOR

Normal GI snack, administered at 10.00 and 16.00 during the test days

Other: Control

Interventions

Intervention OTHER

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.

Experimental

Control OTHER

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.

Control

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead

Study Sites (1)

Singapore Institute for Clinical Trials

Singapore, 117609, Singapore

Location

Related Publications (3)

• 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.

  PMID: 31344892 BACKGROUND

• 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.

  PMID: 24618754 BACKGROUND

• Mohapatra 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.

  PMID: 40419805 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jeroen Schmitt, PhD

  Senior Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization list will be prepared by an independent staff who is not part of the current study. A non-speaking code will be used for each of the snack types. The study team members will be kept blinded to the order of snack given to the participant
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Investigator

Model Details: The study will be carried out according to a decentralized, randomized, placebo controlled, double-blind, cross-over design.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 6, 2023
• Study Start: November 2, 2022
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)