Healthy Clinical Trial
Official title:
A Study of the Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old UK School Children
This study is a 10-week intervention study to examine the acute and chronic effects of daily intake of a 100 % orange juice drink vs control drink on cognitive performance. The study aims to determine if there are any benefits of whole orange juice intake on cognitive performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an improvement in performance at week 10).
This study will employ a randomised 10 week, parallel groups, double blind, placebo
controlled design to investigate the effects of daily supplemental orange juice compared with
an equicaloric placebo orange drink on cognitive performance in 7-10 year old school
children. Following screening, participants will be randomly assigned to one of two
conditions: (1) Active group: 100% orange juice, (2) Placebo group: control drink (containing
equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour). Both
the active and control groups will receive a drink daily for 10 weeks delivered as a
school-based morning intervention administered by researchers. Children will also be given
drinks to consume over the weekends and school holidays monitored by a drink intake diary.
Participants, parents and teachers will be blind to their assigned condition. Researchers
will also be blinded until completion of the data analysis.
Following a practise session at screening (week -1) to familiarise the participants with the
cognitive tests and study drinks, participants will take part in 3 test sessions - at
baseline (Week 0), on Day 1 of intervention (start of Week 1; acute effects) and immediately
post intervention (end of Week 10; chronic effects).
At week -1 (screening) children will be tested for colour blindness (Ishihara test) and
complete the Wechsler abbreviated scale of intelligence (WASI) for screening purposes.
Respiratory peak flow, height, and weight will also be measured to examine the relationship
between cognitive performance and physical activity.
This study design, including both the test day and morning juice supplementation, is intended
to emulate the children's normal routine as far as possible. Each carton of juice will be
provided mid-morning to act as a supplement to their usual diet.
Measures:
The cognitive tests included in the study are listed below:
- Immediate and delayed picture recognition
- Delayed spatial memory
- Tower of Hanoi (executive function - planning/strategy)
- Corsi block tapping test (executive function and working memory)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |