Clinical trial NCT06955975: The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
Official title: The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty at Older Adults
Pre-Frailty
Frailty
Diet
Dietary Fiber
Systemic Inflammatory Response
Keywords: Pectin
LM Pectin
Frailty
Pre-Frailty
Systemic inflammation
Dietary intervention
Gut microbiome
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled intervention
Primary purpose: BASIC_SCIENCE

Brief summary: The study involves intake of Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents) to test their effects on systematic inflammation in the body and gut microbiome composition. Study subjects will be healthy elderly with early signs of frailty or pre-frailty from the local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour (active arm) or 30g of whey protein with 10g of cocoa powder added as flavour (placebo). Participants will be given the blinded products portioned in individual sachets, with instructions to add the contents of one sachet a day to 150ml of milk and to consume immediately.

At each study visit (\~90 minutes), participants will be asked to provide a stool and blood sample, will have blood pressure, heart rate, weight, height, and waist/hip ratio measured, research team will perform physical functioning test (Time up and go test, 30-second sit to stand test) as well as participants will complete the quality-of-life questionnaire (SF-36), the Depression and Anxiety (HADS) and the Gastrointestinal Symptom Rating Scale (GSRS).

Detailed description: The overall aim of the proposed project is to study the effect of daily ingestion of a dietary fibre (LM pectin) among frail population on anti-inflammatory and cardioprotective metabolic measures and to determine whether effects are mediated via the modulation of the gut microbiome and SCFAs production.

Specific Aim 1: To determine the effects of 4-weeks' pectin dietary supplementation on gut microbiome composition and diversity and the concentration of markers of intestinal permeability in the blood.

Specific Aim 2: To investigate the impact of daily pectin intake on physical functioning and subjective quality of life.

Specific Aim 3: To investigate the consequences of 4-weeks' daily ingestion of pectin on subjective measures of depression and anxiety among frail participants.

30 healthy elderly with early signs of frailty or pre-frailty will be recruited following a successful medical screening.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Participant eligibility includes those aged \>65 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2.
* Participants who are considered as pre-frail or frail based on FRAIL (Simple Frailty Questionnaire).

Exclusion Criteria:

* Have gastrointestinal conditions e.g. malabsorptive conditions such as IBS/IBD, coeliac or functional conditions such as gastroparesis or food intolerances etc.
* History of major surgery which potentially limit participation or completion of the study.
* History of gastrointestinal resection surgery, including bariatric surgery.
* Used of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.
* Are taking the following medications: immunosuppressants, amiodarone and/or perhexiline.
* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program.
* History of side effects towards probiotics or prebiotics.
* History or current psychiatric illness.
* History or current neurological condition (e.g. epilepsy).
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.

Primary outcomes:
measure: Change in microbiome profile
timeFrame: 4 weeks
measure: Change in inflammatory profile
timeFrame: 4 weeks
measure: Changes in short chain fatty acids (SCFAs)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in systolic blood pressure (lying to standing) pre intervention
timeFrame: 4 minutes
measure: Change in systolic blood pressure (lying to standing) post intervention
timeFrame: 4 minutes
measure: Change in diastolic blood pressure (lying to standing) pre intervention
timeFrame: 4 minutes
measure: Change in diastolic blood pressure (lying to standing) post intervention
timeFrame: 4 minutes
measure: Change in body mass index (BMI)
timeFrame: 4 weeks
measure: Change in waist-to-hip ratio (WHR)
timeFrame: 4 weeks
measure: Change in time up and go test (TUG)
timeFrame: 4 weeks
measure: Change in 30-second sit to stand test
timeFrame: 4 weeks
measure: Change in Hospital Anxiety and Depression Score (HADS)
timeFrame: 4 weeks
measure: Change in 36-Item Short Form Survey (SF-36) Questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Professor Ana Valdes, PhD student candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Noor K Al-Tameemi, PhD student candidate
role: STUDY_DIRECTOR
References: