SD2908 Magnesium Lotion Sleep Study March/April …...to a better quality of sleep) and the scores were added to give a total score out of 32. The mean total score (Figure 1) at the

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SD2908 Magnesium

Lotion Sleep Study

March/April 2018

Prepared for BetterYou

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Contents

Experimental Details…………………………………………………………………………. pg 3

Project Background………………………………………………………………………………… pg 3

Project Objectives………………………………………………………………………………….. pg 3

Methodology and Data Analysis…………………………………………………………….. pg 3

Samples…………………………………………………………………………………………………. pg 4

Respondents………………………………………………………………………………………….. pg4

Results………………………………………………………………………………………………. pg 5

NHS Sleep Self-Assessment Questionnaire…………………………………………….. pg 5

Quality of Sleep…………………………………………………………………………………….. pg 7

Mood Over Time…………………………………………………………………………………… pg 9

Product Benefits……………………………………………………………………………………. pg 11

Product Liking and Sensory Experience…………………………………………………. pg 12

Conclusions…………………………………………………………………………………….. pg 13

Recommendations………………………………………………………………………… pg 13

Appendix……………………………………………………………………………………………. pg 14

Respondent Attitudes to Exercise, Diet and Stress……………………………. pg 14

Mood Over Time ………………………………………………………………………………….. pg 16

NHS Sleep Self-Assessment Questionnaire……………………………………………. Pg 20

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Experimental Details

Project Background

BetterYou is a specialist in transdermal magnesium products.

Magnesium deficiency is known to be a contributory factor to poor sleep patterns. In

addition, low levels of magnesium can cause muscle cramping and restless leg syndrome both

of which in themselves often contribute to poor sleep quality.

BetterYou has developed a magnesium lotion with aromatherapy oils, designed to improve

sleep quality when used as part of a bed-time routine.

Project Objectives

• What do consumers think about the Magnesium Lotion?

• How does using the Lotion as part of a bed-time routine improve sleep quality?

• How long does it take for these effects to be noticed?

• What marketing claims could be used to promote the Lotion?

Methodology and Data Analysis

Products were placed with 87 healthy adults living in or around Reading, UK. 78 respondents

completed the study.

Baseline measures (of how well respondents were sleeping and how they were feeling) were

collected every day for one week before product was placed with the respondent group.

The lotion was then collected from the Sensory Dimensions facility. Respondents were

instructed to use it as part of their bed-time routine, every day for four weeks. During this

four-week period, an online questionnaire about how well respondents were sleeping and

how they were feeling, was filled in every Tuesday, Thursday and Saturday.

NHS sleep self-assessment data were analysed using paired t-tests to compare data collected

at the beginning and end of the study period.

Data relating to quality of sleep and mood over time were analysed using ANOVA – analyses

were carried out on the individual time points and also on weekly averages.

Agreement with product benefits; distributions of liking scores; and sensory attribute ratings

were summarised as percentages of the respondent cohort.

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Sample

Respondents were given the following instructions for product use:

• Use at least 4 pumps of lotion daily, gently massaging it onto clean, dry skin

• For optimal results, use as part of your bedtime routine, applying after showering or

bathing, up to 30 minutes before sleep.

• Suitable for use all over the body, focus on areas such as the neck, shoulders and legs.

• For external use only. Avoid contact with eyes. Do not use on damaged or broken skin.

Respondents

• 50% aged 30-48, 50% aged 49-65

• 50% male, 50% female

• Not pregnant or breastfeeding

• Broadly healthy and active.

• Self-report as ‘struggling to sleep’

• Self-report as not suffering from sleep apnoea

• Not taking prescribed nutritional supplements containing magnesium

• No allergies to body lotion or other cosmetic or toiletry products, or essential oils

• No chronic or acute skin conditions such as eczema, psoriasis

• Willing to use a body lotion as part of a pre-bedtime routine for the duration of the

study

• Have access to the internet and are willing to give an email address to complete an

online survey for the duration of the study.

• Not employed in marketing, public relations, advertising, journalism, manufacture or

retail of skin care, toiletries, cosmetics, essential oils, pharmaceuticals or nutritional

supplements.

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Results

NHS Sleep Self-Assessment Questionnaire

At the beginning and end of the study, respondents were asked eight questions which make

up the NHS Sleep Self-Assessment Questionnaire (https://www.nhs.uk/Tools/Pages/Sleep-

self-assessment.aspx). Each answer was allocated a score from 0 to 4 (a higher score equates

to a better quality of sleep) and the scores were added to give a total score out of 32.

The mean total score (Figure 1) at the beginning of the baseline week of the study was 10.3

but rose to 16.5 by the end of four weeks of product use – a statistically significant increase

(at the 95% confidence level). This shows that the lotion resulted in a better quality of sleep

across the respondent group.

The biggest changes reported by respondents over the course of the study in response to the

NHS questions (Figure 2 and Table 1) were related to sleep itself, with respondents reporting

an ability to fall asleep more quickly, being awake for less time during the night and

improved sleep quality. Respondents also said that they had a problem with their sleep fewer

days in the week; and reported indirect benefits such as: sleep had less of an effect on their

mood, energy, relationships, concentration, productivity and ability to stay awake; and that

they were less troubled by poor sleep in general. The only measure that did not improve

statistically significantly over the course of the study was the length of time for which

respondents had had a problem with their sleep – these questions were only asked at time

points five weeks apart, not a big enough interval to capture a change in this measure. For

this reason, this question has not been shown in Figure 2. Level of exercise did not influence

the effect of the lotion on these measures.

92% of respondents showed an improvement on at least one of the NHS sleep self-assessment

measures.

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Mean scores n=78 Baseline After 4 weeks product usage

How long did it take you to fall asleep? 1.7 B 2.9 A

If you woke up, how long were you awake for in total? 1.6 B 2.9 A

How many nights a week did you have a problem with your sleep? 0.6 B 1.3 A

How would you rate your sleep quality? 1.1 B 2.1 A

To what extent has poor sleep affected your mood, energy or relationships? 1.5 B 2.2 A

To what extent has poor sleep affected your concentration, productivity or ability to stay awake? 1.7 B 2.4 A

To what extent has poor sleep troubled you in general? 1.6 B 2.3 A

How long have you had a problem with your sleep? 0.4 A 0.4 A

Table 1 Scores which do not share a letter are significantly different from one another at the 95% confidence level.

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Quality of Sleep

Three of the NHS sleep questions (quality of sleep, time taken to fall asleep and time awake)

were asked every time the questionnaire was answered for the duration of the study – this

was every day during the baseline week and three times a week for the four weeks of product

usage (Figures 3, 4 and 5).

From the first week of product use, respondents rated their sleep quality (Figure 3) as

statistically significantly better than baseline (at the 95% confidence level). Respondents also

reported statistically significantly better sleep quality during weeks two, three and four of

product use than in week one.

In addition, respondents reported that it took less time to fall asleep when using the product

than it took before starting to use the product (Figure 4). And they were awake for less time

during the night when using the product (Figure 5).

Week Mean

Baseline 1.5 C

Product Week 1 2.1 B

Product Week 2 2.4 A



Week Mean

Baseline 2.2 C


Product Week 2 2.9 AB



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Week Mean

Baseline 2.1 B





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Mood Over Time

At each time-point, respondents were also asked about their mood and tiredness.

Respondents reported that they felt less tired, happier and more invigorated when using the

product than they did before using the product (Figures 6, 7 and 8). They also reported feeling

more active, rested, sociable, refreshed, energetic, resilient and less fatigued (Figures 17-23,

Appendix 1

Week Mean

Baseline 3.1 A


Product Week 2 2.4 BC

Product Week 3 2.2 C


Week Mean

Baseline 2.5 C





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Week Mean

Baseline 1.8 C





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Product Benefits

At the end of the four weeks of product use, respondents were asked how much they agreed

or disagreed with a variety of statements relating to product benefits.

70% of respondents agreed that their quality of sleep has been better and 69% of

respondents said that they would recommend the lotion to a friend who struggled to sleep.

Over half of respondents also agreed that their sleep had been less interrupted, they felt less

tired and they felt more refreshed when they woke up in the mornings

23% 28%18% 13% 10% 15%

8% 13%

47% 41%

41%42%

42% 33%36% 29%

14% 17%

23%21% 27%

28% 33%

22%

4%8%

8%9% 5% 8% 8%

14%

12%6% 10% 15% 15% 15% 15%

22%

My quality ofsleep has been

better

I wouldrecommend

this lotion to afriend who has

troublesleeping

My sleep hasbeen less

interrupted

I feel less tired I feel morerefreshed

when I wakeup in themornings

My mood hasimproved

I am able toconcentrate

better

I am morelikely to sleepthrough thenight now

How much do you agree or disagree with the following statements? N=78 (Figure 9)

Strongly disagree Slightly disagree Neither agree nor disagree Slightly agree Strongly agree

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Product Liking and Sensory Experience

After using the lotion for four weeks, respondents were asked how much they liked the

product. The lotion was relatively well liked overall, receiving a mean score of 6.8 out of 9

(Table 2). Respondents particularly liked its appearance and texture (which received mean

scores of around 7/9). The aroma was not scored quite so favourably (mean score of 6.5/9) –

feedback from respondents suggested that the aroma was not strong enough and that

lavender is a polarising aroma, with some respondents saying it reminded them of “old ladies”

or it was “medicinal”. There was no effect of age or gender on liking.

Generally, respondents thought that the lotion was easy to apply, relatively quick to absorb

and was not oily (Figures 11, 12 and 13)

N=78 Overall Liking Appearance

Liking Aroma Liking Texture Liking

Mean Score 6.8 7.1 6.5 7.0

9% 8%15%

10%

31%38% 24%

41%

31%27%

19%

23%

8%10%

9%

6%

12%13%

14%

5%

5%3%

8%8%

4% 1%

4%6%

1% 0%6%

0%0% 0% 0% 0%Overall Liking Appearance liking Aroma Liking Texture Liking

N=78 (Figure 10)

Dislike extremely

Dislike very much

Dislike moderately

Dislike slightly

Neither like nor dislike

Like slightly

Like moderately

Like very much

Like extremely

63%

28%

6%3%0%

Ease of application N=78 (Figure 11)

Verydifficult toapplyQuitedifficult toapplyNeither easynor difficultto applyQuite easyto apply

Very easy toapply

9%

41%

35%

10%

5%

Speed of absorption N=78 (Figure 12)

Extremelyslow

Very slow

Moderate

Very fast

Extremelyfast

1%8%

24%

29%

37%

OilinessN=78 (Figure 13)

Not at alloily

Slightly oily

Moderatelyoily

Very oily

Extremelyoily

Table 2

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Conclusions

Overall the lotion performed very well, resulting in an improvement in respondent responses

to the NHS sleep self-assessment questionnaire (an increase from 10.3 to 16.5). A statistically

significant improvement was seen in response to all but one of the questions which make up

the NHS questionnaire.

Respondents reported that after using the product their quality of sleep was better, they fell

asleep quicker and they were awake for less time during the night – all these benefits were

seen from the first week of product use onwards. Similar benefits were reported with regards

to mood and tiredness, with respondents reporting feeling happier, more sociable, more

active, more rested, more invigorated, more refreshed, more energetic, more resilient, less

tired and less fatigued within a week of beginning to use the product.

70% of respondents agreed that their quality of sleep was been better when using the lotion

and 69% of respondents said that they would recommend the lotion to a friend who struggled

to sleep. Over half of respondents also agreed that their sleep had been less interrupted, they

felt less tired and they felt more refreshed when they woke up in the mornings.

The lotion was relatively well liked overall, and respondents particularly liked the appearance

and texture. Some respondents criticised the aroma for being too weak, while other

respondents disliked the lavender aroma, saying that it reminded them of “old ladies” or was

“medicinal”.

The effect of the product cannot be separated from a placebo effect, as no control product

was used. However, the trial represents a realistic use situation. Additionally, the extent to

which the improvements were due to a change in bed-time routine cannot be known.

Recommendations

The product performed well with the respondent group but may benefit from an increase in

aroma strength. However, there is a risk of alienating those respondents who dislike the

lavender aroma.

The following claims could be made:

• Using the lotion resulted in a statistically significant improvement in self-reported

quality of sleep (using the NHS Sleep Self-Assessment Questionnaire)

• After using the lotion respondents felt less tired, happier and more invigorated

• 70% of respondents agreed that their quality of sleep was better after using the lotion

• 69% of respondents said that they would recommend the lotion to a friend who

struggled to sleep

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Appendix

Respondent attitudes to exercise, diet and stress

Information about respondent attitudes to exercise, diet and stress was collected to give

background information about the respondent group. There was a spread of regularity of

exercise amongst the group from every day to less than once a month (Figure 14).

Respondents reported a moderate quality of diet (Figure 15) and moderate stress levels

(Figure 16).

17%

15%

26%

21%

10%

10%

1%

Thinking about the last year, how often have you participated in some kind of exercise?

N=78 (Figure 14)

Every day

5-6 times per week

3-4 times per week

1-2 times per week

1-2 times per month

Less often

Never

3%

38%

38%

19%

1%

Thinking about the last year, please select the statement that best describes your diet:

N=78 (Figure 15)

I eat healthily all the time

I eat healthily most of the time but haveoccasional treats

I eat healthily about half of the time

I don't often eat as healthily as I should,but I have occasional healthy days

I don't ever eat as healthily as I should

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0%

23%

42%

33%

1%

Thinking about the last year, please select the statement that best describes your stress level:

N=78 (Figure 16)

I am always stressed

I am stressed most of the time

I am stressed about half of thetime

I am occasionally stressed

I am never stressed

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Mood Over Time

Week Mean

Baseline 2.3 C





Week Mean

Baseline 2.1 C





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Week Mean

Baseline 2.4 C





Week Mean

Baseline 1.9 C





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Week Mean

Baseline 2.0 C





Week Mean

Baseline 2.3 C





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Week Mean

Baseline 2.8 A



Product Week 3 2.1 C


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NHS Sleep Self-Assessment Questionnaire

Thinking about a typical night in the last month, how long did it take you to fall asleep?

0-15 minutes 4

16-30 minutes 3

31-45 minutes 2

46-60 minutes 1

More than 61 minutes 0

Thinking about a typical night in the last month, if you woke up, how long were you awake for

in total?

0-15 minutes 4

16-30 minutes 3

31-45 minutes 2

46-60 minutes 1

More than 61 minutes 0

Thinking about the last month, how many nights a week did you have a problem with your

sleep?

0-1 nights 4

2 nights 3

3 nights 2

4 nights 1

5-7 nights 0

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Thinking about a typical night in the last month, how would you rate your sleep quality?

Very good 4

Good 3

Average 2

Poor 1

Very poor 0

Thinking about the past month, to what extent has poor sleep affected your mood, energy,

or relationships?

Not at all 4

A little 3

Somewhat 2

Much 1

Very much 0

Thinking about the past month, to what extent has poor sleep affected your concentration,

productivity, or ability to stay awake?

Not at all 4

A little 3

Somewhat 2

Much 1

Very much 0

Thinking about the past month, to what extent has poor sleep troubled you in general?

Not at all 4

A little 3

Somewhat 2

Much 1

Very much 0

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How long have you had a problem with your sleep?

I don’t have a problem (or I’ve had a problem for less than 1 month) 4

1-2 months 3

3-6 months 2

7-12 months 1

Longer than a year 0

Documents

SD2908 Magnesium Lotion Sleep Study March/April …...to a better quality of sleep) and the scores were added to give a total score out of 32. The mean total score (Figure 1) at the