A Decentralized Study on Dietary Influences on Cognitive Functions

NCT ID: NCT05801731

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2023-02-17

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.

Conditions

Glucose Metabolism; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Intervention

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Human Development and Potential (IHDP), Singapore

OTHER

Sponsor Role: lead

Responsible Party

Jeroen Schmitt

Senior Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeroen Schmitt, PhD

Role: PRINCIPAL_INVESTIGATOR

Senior Principal Investigator

Locations

Singapore Institute for Clinical Trials

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 31344892 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24618754 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40419805 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-059

Identifier Type: -

Identifier Source: org_study_id