Mild Cognitive Impairment Clinical Trial
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.
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.
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