Caffeine, DNA and Cognition

NCT05806476 | Unknown

• 1 other identifier: SMU_ETHICS_2021-22-319
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

A study investigating the effects of acute caffeine intake on cognition based on genes associated with caffeine metabolism and physiological effect.

Conditions

Cognitive Function 1, Social

Keywords

cognition; caffeine; attention; memory; executive function; emotion recognition; genetics

Outcome Measures

Primary Outcomes (4)

• Attention and psychomotor speed

  Attention and psychomotor speed is assessed using the Psychomotor Vigilance Task (PVT). The reaction times to optical stimulus (red dot) on the screen, measured in milliseconds will be used as a measure.

  8 min online task on 4 timepoints (n=4) on all experimental days (n=4)

• Memory

  Memory is assessed using the N-back letter task. The reaction times for correct answers (was the letter on the screen displayed one/two/three letters ago? Yes or No), measured in milliseconds will be used as a measure.

  6 min online task on 4 timepoints (n=4) on all experimental days (n=4)

• Emotion recognition

  Emotion recognition is assessed using the Karolinska Directed Emotional Faces. The reaction times for correct answers (what emotion does the person on the picture show? Anger, Fear, Disgust, Happiness, Sadness, Surprise), measured in milliseconds will be used as a measure.

  4 min online task on 4 timepoints (n=4) on all experimental days (n=4)

• Executive function

  Executive function is assessed using the Stroop colour and word task. The reaction times for correct answers (name the word and name the colour of the word), measured in milliseconds will be used as a measure.

  5 min online task on 4 timepoints (n=4) on all experimental days (n=4)

Study Arms (4)

C - C

EXPERIMENTAL

caffeine intake during the run-in days and caffeine intake on the experimental day

Dietary Supplement: caffeine

C - P

EXPERIMENTAL

caffeine intake during the run-in days and placebo intake on the experimental day

Dietary Supplement: caffeine; Dietary Supplement: placebo

P - P

EXPERIMENTAL

placebo intake during the run-in days and placebo intake on the experimental day

Dietary Supplement: placebo

P - C

EXPERIMENTAL

placebo intake during the run-in days and caffeine intake on the experimental day

Dietary Supplement: caffeine; Dietary Supplement: placebo

Interventions

caffeine DIETARY_SUPPLEMENT

1.75mg / kg body mass of caffeine x 3 times a day during the run-in days and 3mg / body mass of caffeine once on the experimental days

C - C; C - P; P - C

placebo DIETARY_SUPPLEMENT

1.75mg / kg body mass of microcrystalline cellulose x 3 times a day during the run-in days and 3mg / body mass of microcrystalline cellulose once on the experimental days

C - P; P - C; P - P

Eligibility Criteria

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

You may qualify if:

• \) adult males and females 18-65 years; 2) who habitually consume caffeine; 3) free from any known disease; 4) free from medication, including contraceptive pills; 5) without uncorrected vision issues, e.g., having myopia but not wearing eyeglasses or daltonism (colour blindness); 6) non-smokers (to avoid contributory effects of nicotine or other tobacco substances to caffeine effects or tolerance) and 7) non-pregnant or breastfeeding.

You may not qualify if:

• \) individuals with a chronic medical condition, 2) pregnant or lactating women, 3) regularly taking medication, including contraceptive pills, 4) with uncorrected vision, 5) smokers, 6) individuals who habitually consume alcohol more than the publicly recommended upper safe limits (21 and 14 units per week for men and women, respectively) and 7) not providing written informed consent.

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead

Study Sites (2)

St Mary's University Twickenham

London, Lobdon, TW1 4SX, United Kingdom

RECRUITING

St Mary's University

London, TW14SX, United Kingdom

RECRUITING

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the researchers prepared the caffeine and placebo capsules and someone outside the research team blinded them so that both the investigators and the participants were blinded. Identical opaque capsules were used for both caffeine and placebo
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: February 22, 2023
• Primary Completion: April 4, 2023
• Study Completion: May 30, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)