The Effects of Diet on Mood, Cognition and Appetite
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Fat Low Carbohydrate Diet
Low fat High Carbohydrate Diet
Sponsored by

About this trial
This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring Cognitive function, mood, women, high fat diet, high carbohydrate diet
Eligibility 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)
Sites / Locations
- University of Nottingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High fat, low carbohydrate diet
Low fat, high carbohydrate diet
Arm Description
Fats intake 55% , Protein 17% and carbohydrate 28% of total energy
Fat intake 20%, Protein 17% and carbohydrate 63% of total energy intake
Outcomes
Primary Outcome Measures
Clear-headedness
Subjective mood measurement, assessed using visual analogue scale, in response to a test meal
Secondary Outcome Measures
Reaction time
cognitive function measurement, assessed using choice reaction time, in response to a test meal
Full Information
NCT ID
NCT01201616
First Posted
September 13, 2010
Last Updated
March 23, 2018
Sponsor
University of Nottingham
Collaborators
Mars, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01201616
Brief Title
The Effects of Diet on Mood, Cognition and Appetite
Official Title
The Effects of a High Fat, Low Carbohydrate or a Low Fat, High Carbohydrate Diet on Mood Cognition and Appetite
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham
Collaborators
Mars, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Cognitive function, mood, women, high fat diet, high carbohydrate diet
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High fat, low carbohydrate diet
Arm Type
Experimental
Arm Description
Fats intake 55% , Protein 17% and carbohydrate 28% of total energy
Arm Title
Low fat, high carbohydrate diet
Arm Type
Active Comparator
Arm Description
Fat intake 20%, Protein 17% and carbohydrate 63% of total energy intake
Intervention Type
Other
Intervention Name(s)
High Fat Low Carbohydrate Diet
Other Intervention Name(s)
HFLC Diet
Intervention Description
55% total energy intake from fats, 17% from protein and 28% from carbohydrate
Intervention Type
Other
Intervention Name(s)
Low fat High Carbohydrate Diet
Other Intervention Name(s)
LFHC Diet
Intervention Description
20% total energy intake from dietary fats, 17% from protein and 63% from carbohydrate
Primary Outcome Measure Information:
Title
Clear-headedness
Description
Subjective mood measurement, assessed using visual analogue scale, in response to a test meal
Time Frame
after 2 week intervention period
Secondary Outcome Measure Information:
Title
Reaction time
Description
cognitive function measurement, assessed using choice reaction time, in response to a test meal
Time Frame
after 2 week intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian A Macdonald, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Notts
ZIP/Postal Code
NG72UH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
9537627
Citation
Benton D, Parker PY. Breakfast, blood glucose, and cognition. Am J Clin Nutr. 1998 Apr;67(4):772S-778S. doi: 10.1093/ajcn/67.4.772S.
Results Reference
background
PubMed Identifier
9537633
Citation
Pollitt E, Mathews R. Breakfast and cognition: an integrative summary. Am J Clin Nutr. 1998 Apr;67(4):804S-813S. doi: 10.1093/ajcn/67.4.804S.
Results Reference
background
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The Effects of Diet on Mood, Cognition and Appetite
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