Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorKing's College London
About this trial
This is a clinical trial aimed to investigate if a novel phytochemical and fibre-rich snack can improve perimenopausal symptoms and well-being in perimenopausal women aged 40-55 and not on hormone replacement therapy.
Hypothesis: The investigators hypothesise that the phytochemical and fibre-rich snack will improve perimenopausal symptoms via a gut microbiota mediated mechanism.
Main research questions:
Does eating the snack every day lower menopause symptoms such as hot flushes, night sweats, mood changes, and sleep problems? Does the snack improve mood, stress, anxiety, sleep, and overall quality of life? Does the snack improve the balance of bacteria in the gut, and could this be part of how it helps symptoms?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 40 to 55
Score 14 or higher on the Menopause Rating Scale
For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
Disqualifiers
People who consume more than 15g of fibre a day
People who consume more than 2 cups of coffee or tea a day
People who consume more than 4 portions (portion = 80g) of fruits and vegetables a day
Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts
Trial design
Design model
Crossover
Treatments tested in this trial
Functional Snacks
Dietary supplementA type of phytochemical and fibre rich snack that created and produced by TulaCode called Cinnamon Granola Bark (50 g per pouch). The snack contains the following ingredients: Amaranth, coconut flakes, chia seeds, pumpkin seeds, sunflower seeds, pecans, brazil nuts, almonds, dates, banana, cold pressed extra virgin olive oil, 100% cocoa mass, cocoa butter, chicory root fibre, cinnamon, cloves, nutmeg, ginger, ground vanilla pod, natural Bourbon vanilla flavouring, salt
Placebo Snacks
Other interventionA type of calorie-matched commercially available chocolate snack, Mini Cornflake Cluster Bites (50 g per pouch). The snack contains the following ingredients: Milk chocolate (60%) (sugar, cocoa butter, cocoa mass, skimmed milk powder, milk fat, lactose (milk), emulsifier (soya lecithin)), corn flakes (40%) (maize, sugar, salt, barley malt extract, dextrose, niacin, iron, vitamin B6, riboflavin, vitamin B1, folic acid, vitamin B12)
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: functional snacks then placebo snacksExperimental treatment 2 interventions
Group B: placebo snacks then functional snacksExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in menopause rating scale (MRS) of perimenopausal women
To assess menopause-related symptoms of perimenopausal women, using the menopause rating scale (MRS). The scale consists in 11 items ranging from 0 (none) to 4 (very severe).
Time frame
Baseline & 4 weeksSecondary outcomes
1
Changes in subjective (perceived) stress level of perimenopausal women
The subjective stress level of perimenopausal women are assessed using the Perceived Stress Scale (PSS) questionnaire. The scale consists in 10 items rated on a 5-point Likert scale.
Time frame
Baseline & 4 weeks2
Changes in affect in perimenopausal women
To assess the affect of perimenopausal women, using the Positive and Negative Affect Schedule (PANAS-SF) questionnaire, consisting of 20 items rated from 1 (very slightly or not at all) to 5 (extremely).
Time frame
Baseline & 4 weeks3
Changes in female sex hormone levels of perimenopausal women
To assess the female sex hormone levels of perimenopausal women, measured several esterone levels in blood samples using the randox clinical biochemistry analyser.
Time frame
Baseline & 4 weeks4
Changes in cognitive function of perimenopausal women
To assess cognitive function of perimenopausal womenm using Cognitive Failures questionnaire (CFQ). The questionnaire consists of 25 questions rated on a 5-point Likert scale from 0 ("Never") to 4 ("Very often").
Time frame
Baseline & 4 weeksOther outcomes
1
Plasma and Urinary metabolites of (poly)phenols of perimenopausal women
In total more than 160 phenolic compounds and phase 2 metabolites will be measured in plasma and urine samples by LC-MS.
Time frame
Baseline and 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Tulā Code Ltd
Collaborator
Source ClinicalTrials.gov