NCT03346746

Brief Summary

This study provides participants with two diets that vary in their glycaemic index values (low vs. high), whilst also measuring cognitive performance and mood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

November 9, 2017

Last Update Submit

November 14, 2017

Conditions

Cognitive PerformanceGlucose, Low BloodGlucose, High BloodMood

Keywords

cognitionglycaemicmooddiet

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive performance between time points assessed

    A participants performance over four cognitive tasks

    This was tested 9 times a day, with two days, giving a total of 18 times. Each battery of four tasks lasted approximately 15 minutes

Secondary Outcomes (5)

  • Glycaemic profile

    This was measured 23 times a day, for two days, giving a total of 46 times

  • Mood (alertness, anxiety and contentment) using the Bond-Lader (1974) Visual Analogue Scale

    This takes approximately 5 minutes to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 60 minutes of mood scale completion.

  • Sleepiness

    This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.

  • Hunger

    This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.

  • Fullness

    This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.

Study Arms (2)

Low GI diet

EXPERIMENTAL

This diet contained three Low GI meals. This was the Low Glycaemic Diet intervention.

Dietary Supplement: Low Glycaemic Diet

High GI diet

EXPERIMENTAL

This diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention.

Dietary Supplement: High Glycaemic Diet

Interventions

Low Glycaemic DietDIETARY_SUPPLEMENT

This intervention was a diet that provided participants with three meals with a low GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).

Low GI diet
High Glycaemic DietDIETARY_SUPPLEMENT

This intervention was a diet that provided participants with three meals with a high GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).

High GI diet

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 25 years of age
  • Willing to participate in the entire study (signed informed consent required)
  • Male or female (not pregnant)

You may not qualify if:

  • Suffer from diabetes
  • Are anaemic
  • Smoker
  • Have any food intolerances or allergies
  • History of alcohol or drug misuse
  • Diagnosed with any of the following;
  • High blood cholesterol
  • High blood pressure
  • Thyroid disorder
  • Heart problems, stroke or any vascular disease in the past 12 months
  • Inflammatory diseases such as rheumatoid arthritis
  • Bone related conditions, such as osteoporosis
  • Renal, gastrointestinal, respiratory, liver disease or cancer
  • You are presently taking part in another clinical trial or research study
  • You are an elite athlete (very high intensity training more than 3 times a week)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Study Officials

  • Daniel J Lamport, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not told what diet they were consuming each day.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: All participants took part in both conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 17, 2017

Study Start

February 1, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)