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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Nottingham

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pectin

    Dietary supplement

    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.

  • Whey protein

    Other intervention

    10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PectinActive comparator 1 intervention
Group B: Whey proteinPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in microbiome profile

Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period.

Time frame
4 weeks
2

Change in inflammatory profile

Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period.

Time frame
4 weeks
3

Changes in short chain fatty acids (SCFAs)

Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period.

Time frame
4 weeks

Secondary outcomes

1

Change in systolic blood pressure (lying to standing) pre intervention

Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit.

Time frame
4 minutes
2

Change in systolic blood pressure (lying to standing) post intervention

Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit

Time frame
4 minutes
3

Change in diastolic blood pressure (lying to standing) pre intervention

Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit.

Time frame
4 minutes
4

Change in diastolic blood pressure (lying to standing) post intervention

Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit.

Time frame
4 minutes

Other outcomes

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