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The Effects of Diet on Mood, Cognition and Appetite

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ClinicalTrials.gov Identifier: NCT01201616
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
Elizabeth Simpson, University of Nottingham

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 Phase
Mild Cognitive Impairment Other: High Fat Low Carbohydrate Diet Other: Low fat High Carbohydrate Diet Not Applicable

  Show Detailed Description

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
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

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




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



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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)

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

Publications:
Responsible Party: Elizabeth Simpson, Senior Research Fellow, 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: March 27, 2018
Last Verified: March 2018

Keywords provided by Elizabeth Simpson, 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