The Effects of Diet on Mood, Cognition and Appetite

March 23, 2018 updated by: Elizabeth Simpson, University of Nottingham

The Effects of a High Fat, Low Carbohydrate or a Low Fat, High Carbohydrate Diet on Mood Cognition and Appetite

A previous study has found that the consumption of a high fat, low carbohydrate meal results in increased feelings of calmness, friendliness and an increase in subjective energy levels in comparison to a low fat, high carbohydrate meal. The purpose of this study is to investigate whether a high fat, low carbohydrate diet for a longer duration (of 2 weeks) can enhance or sustain these changes in comparison to a low fat, high carbohydrate meal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research has shown that consuming breakfasts high in either fat or carbohydrates can affect a persons memory, mood and ability to concentrate (Benton & Parker, 1998, Politt & Mathews, 1998). Our previous study investigating the effect of a high fat, low carbohydrate (HFLC) meal in comparison to a low fat, high carbohydrate (LFHC) meal found that the HFLC meal resulted in significantly increased feelings of calmness, friendliness and a reduction in feelings of anger, and an increase in subjective energy levels in comparison to a LFHC meal. However, the chronic effects of a HFLC or LFHC diet has not been studied. This purpose of this study is to investigate whether a 2 week diet high in either fat or carbohydrates improves cognition/memory and mood. It is hypothesised that the prolonged feeding of a HFLC diet will attenuate the response seen after a HFLC meal was provided.

Twenty healthy women are required to attend the School of Biomedical Sciences on seven occasions.

The first visit will involve screening tests for suitability for inclusion in the study and written, informed consent will be obtained. Weight, height and blood pressure will be measured and a 5ml blood sample will be collected for full blood count, urea, electrolytes and random blood glucose assessment. Subjects will be asked to complete questionnaires regarding general health, eating habits, mood and medical history. Following the screening visit, subjects will be asked to record their habitual food intake and physical activity pattern for a 3 day period (2 weekdays and 1 weekend day. They will then attend the laboratory on 6 further occasions, once for a familiarisation visit and for the 5 study visits.

The familiarisation visit is required to ensure that subjects are comfortable and familiar with using the cognitive tests which will be administered.

Subjects will be provided with a menu of foods to consume as their evening meal prior to study visits, based on 30% total energy expenditure. This meal will be based on foods the subject recorded in the completed food diary and will contain approximately 15% of total energy from protein, 55% from carbohydrate and 30% from fat. Before study visits subjects will be instructed to consume this standardised meal as their last meal of the day before 20.00 on the previous evening. After they have consumed this meal they are instructed not to consume any foods or drinks apart from water until they arrive at the lab.

Subjects will arrive (fasted) at the lab at 08.00 on the morning of each study visit. A cannula will be inserted retrograde into a hand vein, after prior infiltration at insertion site with 1% lidocaine. The hand will be placed in a heated box, and remain there throughout the trial, to obtain arterialised venous blood samples. The cannula will be kept patent with a slow infusion of 0.9% saline, and samples will be taken via a three-way tap.

Subjects will then be either given a HFLC, or a LFHC breakfast, the order being randomised. The HFLC breakfast will be provided on study days before and after the HFLC diet intervention, and the LFHC breakfast will be provided on study days before and after the LFHC diet intervention.

Water will be freely available throughout the day. Every 30 minutes subjects will be asked to complete a set of visual analogue scales designed to assess subjective mood and satiety, a 15ml blood sample will be taken for the measurement of glucose, insulin, ghrelin, free fatty acids, glucagon, cholecystokinin (CCK), Glucagon-like peptide 1 (GLP-1), cortisol, adrenaline and noradrenaline. A 3ml sample will be taken every 15minutes for the first 90 minutes, for the analysis of insulin and glucose. A baseline sample for triglycerides and cholesterol will be taken at the beginning of each study visit. Cognitive tests (measuring attention reaction times and vigilance) will be completed 0, 45, 90 and 135 minutes minutes after the provision of breakfast. After 180 minutes, the cannula will be removed and subjects will be free to leave the lab.

Subjects will be provided with either a HFLC diet or a LFHC diet to consume for 2 weeks. These diets will be designed to meet subjects energy requirements. After consuming the diet for 2 weeks (diets will comprise of 3 meals and 3 snacks per day), subjects will return to the laboratory for the second study visit. Subjects will be provided with a set of visual analogue scales to complete on days 4, 8 and 12 of the intervention period. Subjects will then return to their habitual diets for 2 weeks, before completing the second intervention.

Subjects will also be asked to come to the laboratory for an additional study visit either 2 days before visit 1 or two days before visit 3, where they will be consume their habitual breakfast instead of a HFLC or LFHC breakfast.

During both the 2 week intervention periods, subjects will be asked to consume only the food provided, no other drinks, including alcohol and caffeinated drinks, may be consumed. If subjects are habitual tea/coffee drinkers then they may consume a maximum of 3 cups of tea/coffee a day (unsweetened, with milk from their daily allocation) and be asked to maintain this over both arms of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Notts
      • Nottingham, Notts, United Kingdom, NG72UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • BMI 18.5-25kg/m2
  • aged 18-45 years
  • regular breakfast eaters
  • regular menstrual cycle
  • healthy

Exclusion Criteria:

  • Significant gastrointestinal disease, gastrointestinal surgery, diabetes or any other significant major medical morbidity
  • History of significant eating disorder (anorexia, bulimia)
  • Habitual dietary protein intake >20% of total energy intake
  • pregnancy or breast feeding
  • anaemia (Hb <11.5g/dL)
  • random blood glucose concentration >8mmol/l
  • no medication use other than contraception
  • significant weight loss/gain (>14lb in previous 3 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High fat, low carbohydrate diet
Fats intake 55% , Protein 17% and carbohydrate 28% of total energy
Other: High Fat Low Carbohydrate Diet
55% total energy intake from fats, 17% from protein and 28% from carbohydrate
Other Names:
  • HFLC Diet
Active Comparator: Low fat, high carbohydrate diet
Fat intake 20%, Protein 17% and carbohydrate 63% of total energy intake
Other: Low fat High Carbohydrate Diet
20% total energy intake from dietary fats, 17% from protein and 63% from carbohydrate
Other Names:
  • LFHC Diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clear-headedness
Time Frame: after 2 week intervention period
Subjective mood measurement, assessed using visual analogue scale, in response to a test meal
after 2 week intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reaction time
Time Frame: after 2 week intervention
cognitive function measurement, assessed using choice reaction time, in response to a test meal
after 2 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mars, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIS030426a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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