The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study

Обзор

The study involves the 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 10g 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).

Подробное описание

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.

Вмешательства

• Пищевая добавка Pectin
  10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour were randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.
• Другое Whey protein
  10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin.

Первичные конечные точки

• Change in microbiome profile [Срок оценки: 4 weeks]
• Change in inflammatory profile [Срок оценки: 4 weeks]
• Changes in short chain fatty acids (SCFAs) [Срок оценки: 4 weeks]

Вторичные конечные точки (10)

• Change in systolic blood pressure (lying to standing) pre intervention [Срок оценки: 4 minutes]
• Change in systolic blood pressure (lying to standing) post intervention [Срок оценки: 4 minutes]
• Change in diastolic blood pressure (lying to standing) pre intervention [Срок оценки: 4 minutes]
• Change in diastolic blood pressure (lying to standing) post intervention [Срок оценки: 4 minutes]
• Change in body mass index (BMI) [Срок оценки: 4 weeks]
• Change in waist-to-hip ratio (WHR) [Срок оценки: 4 weeks]
• Change in time up and go test (TUG) [Срок оценки: 4 weeks]
• Change in 30-second sit to stand test [Срок оценки: 4 weeks]
• Change in Hospital Anxiety and Depression Score (HADS) [Срок оценки: 4 weeks]
• Change in 36-Item Short Form Survey (SF-36) Questionnaire [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Великобритания · 1 центр

• University of Nottingham — Nottingham

Идентификаторы

NCT: NCT06955975 · FMHS 280-0924

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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