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Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being

NCT07599930 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-20

No results posted yet for this study

Summary

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?

Conditions

  • Perimenopause
  • Perimenopause-Related Depression
  • Mood
  • Sleep
  • Quality of Life
  • Gut -Microbiota

Interventions

DIETARY_SUPPLEMENT

Functional Snacks

A 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

OTHER

Placebo Snacks

A 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)

Sponsors & Collaborators

Principal Investigators

  • Ana Rodriguez-Mateos, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599930 on ClinicalTrials.gov