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The Effects of Diet on Mood, Cognition and Appetite

This study is currently recruiting participants.
Verified December 2012 by University of Nottingham
Sponsor:
Collaborator:
Mars, Inc.
Information provided by:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01201616
First received: September 13, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Dietary Induced Cognitive Function Impairment
 Other: dietary manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Clear-headedness [ Time Frame: after 2 week intervention period ] [ Designated as safety issue: No ]
    Subjective mood measurement, assessed using visual analogue scale, in response to a test meal


Secondary Outcome Measures:
  • Reaction time [ Time Frame: after 2 week intervention ] [ Designated as safety issue: No ]
    cognitive function measurement, assessed using choice reaction time, in response to a test meal


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fat, low carbohydrate diet
Fats intake 55% , Protein 17% and carbohydrate 28% of total energy
 Other: dietary manipulation
HFLC Diet: 55% total energy intake from fats, 17% from protein and 28% from carbohydrate or LFHC Diet: 20% total energy intake from fats, 17% from protein and 63% from carbohydrate
Active Comparator: Low fat, high carbohydrate diet
Fat intake 20%, Protein 17% and carbohydrate 63% of total energy intake
 Other: dietary manipulation
HFLC Diet: 55% total energy intake from fats, 17% from protein and 28% from carbohydrate or LFHC Diet: 20% total energy intake from fats, 17% from protein and 63% from carbohydrate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201616

Contacts
Contact: Jane E Krause, MNutr +44(0)1158230248 mbxjk@nottingham.ac.uk
Contact: Ian A Macdonald, PhD +44(0)1158230119 ian.macdonald@nottingham.ac.uk

Locations
United Kingdom
University of Nottingham Recruiting
Nottingham, Notts, United Kingdom, NG72UH
Contact: Jane E Krause, MNutr     +44(0)1158230248     mbxjk@nottingham.ac.uk    
Principal Investigator: Ian A Macdonald, PhD            
Sponsors and Collaborators
University of Nottingham
Mars, Inc.
Investigators
Principal Investigator: Ian A Macdonald, PhD University of Nottingham
  More Information

Publications:

Responsible Party: Professor Ian Macdonald, University of Nottingham
ClinicalTrials.gov Identifier: NCT01201616     History of Changes
Other Study ID Numbers: RIS030426a
Study First Received: September 13, 2010
Last Updated: December 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013