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The Effects of Diet on Mood, Cognition and Appetite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01201616
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : August 21, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Mild Cognitive Impairment Other: High Fat Low Carbohydrate Diet Other: Low fat High Carbohydrate Diet

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of a High Fat, Low Carbohydrate or a Low Fat, High Carbohydrate Diet on Mood Cognition and Appetite
Study Start Date : July 2010
Primary Completion Date : December 2012
Study Completion Date : March 2013
Arms and Interventions

Arm Intervention/treatment
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 Name: 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 Name: LFHC Diet


Outcome Measures

Primary Outcome Measures :
  1. Clear-headedness [ Time Frame: after 2 week intervention period ]
    Subjective mood measurement, assessed using visual analogue scale, in response to a test meal


Secondary Outcome Measures :
  1. Reaction time [ Time Frame: after 2 week intervention ]
    cognitive function measurement, assessed using choice reaction time, in response to a test meal


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201616


Locations
United Kingdom
University of Nottingham
Nottingham, Notts, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
Mars, Inc.
Investigators
Principal Investigator: Ian A Macdonald, PhD University of Nottingham
More Information

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01201616     History of Changes
Other Study ID Numbers: RIS030426a
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by University of Nottingham:
Cognitive function
mood
women
high fat diet
high carbohydrate diet

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders