The Effects of Diet on Mood, Cognition and Appetite

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014