Mild Cognitive ImpairmentNCT01201616
The Effects of Diet on Mood, Cognition and Appetite
A study testing High Fat Low Carbohydrate Diet and Low fat High Carbohydrate Diet in people with Mild Cognitive Impairment, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- High Fat Low Carbohydrate Diet and Low fat High Carbohydrate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- BMI 18.5-25kg/m2
- aged 18-45 years
- regular breakfast eaters
- regular menstrual cycle
- healthy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Notts, NG72UH
About this study
Official title: The Effects of a High Fat, Low Carbohydrate or a Low Fat, High Carbohydrate Diet on Mood Cognition and Appetite
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- High Fat Low Carbohydrate Diet, Low fat High Carbohydrate Diet
- Keywords
- Cognitive function, mood, women, high fat diet, high carbohydrate diet
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fat Low Carbohydrate DietOther
Also called HFLC Diet
55% total energy intake from fats, 17% from protein and 28% from carbohydrate
Low fat High Carbohydrate DietOther
Also called LFHC Diet
20% total energy intake from dietary fats, 17% from protein and 63% from carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| High fat, low carbohydrate diet | Experimental | Fats intake 55% , Protein 17% and carbohydrate 28% of total energy Receives: Other: High Fat Low Carbohydrate Diet |
| Low fat, high carbohydrate diet | Active comparator | Fat intake 20%, Protein 17% and carbohydrate 63% of total energy intake Receives: Other: Low fat High Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clear-headedness
Subjective mood measurement, assessed using visual analogue scale, in response to a test meal
Measured: after 2 week intervention period
Secondary outcomes (1)
Reaction time
cognitive function measurement, assessed using choice reaction time, in response to a test meal
Measured: after 2 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc.
- Responsible party
- Principal investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Ian A Macdonald, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201616
- Sponsor's protocol ID
- RIS030426a
- Status last verified
- Mar 2018
- First submitted
- 13 Sep 2010
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9537627Pollitt 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.
PubMed 9537633
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Fat, Low Carbohydrate or a Low Fat, High Carbohydrate Diet on Mood Cognition and Appetite
- ClinicalTrials.gov ID
- NCT01201616
- Acronym / sponsor ID
- RIS030426a
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognitive function, mood, women, high fat diet, high carbohydrate diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat, low carbohydrate diet | Experimental | Other: High Fat Low Carbohydrate DietFats intake 55% , Protein 17% and carbohydrate 28% of total energy |
| Low fat, high carbohydrate diet | Active comparator | Other: Low fat High Carbohydrate DietFat intake 20%, Protein 17% and carbohydrate 63% of total energy intake |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- female
- BMI 18.5-25kg/m2
- aged 18-45 years
- regular breakfast eaters
- regular menstrual cycle
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fat Low Carbohydrate DietAlso: HFLC Diet55% total energy intake from fats, 17% from protein and 28% from carbohydrate | Other | High fat, low carbohydrate diet |
| Low fat High Carbohydrate DietAlso: LFHC Diet20% total energy intake from dietary fats, 17% from protein and 63% from carbohydrate | Other | Low fat, high carbohydrate diet |
Primary outcome
Clear-headedness
Time frame: after 2 week intervention period
Subjective mood measurement, assessed using visual analogue scale, in response to a test meal
1 secondary outcome
Reaction time
Time frame: after 2 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Background: PubMed 9537627Benton 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.
- Background: PubMed 9537633Pollitt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian A Macdonald, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fat Low Carbohydrate Diet and Low fat High Carbohydrate Diet in people with Mild Cognitive Impairment, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clear-headedness (time frame: after 2 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.