Frailty at Older AdultsGEOFFNCT06955975
The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
A study testing Pectin and Whey protein in people with Frailty at Older Adults and Pre-Frailty, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty at Older Adults, Pre-Frailty, Frailty
- What is being tested?
- Pectin and Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Noor K Al-Tameemi, PhD student candidate contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, Nottingham, NG7 2UH
Noor K Al-Tameemi, PhD Student Candidate, 004401158231149, noorkifahabdulhussein.al-tameemi@nottingham.ac.uk
Professor Ana Valdes, 00440115 969 1169, Ana.Valdes@nottingham.ac.uk
About this study
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).
Read the 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.
- Conditions
- Frailty at Older Adults, Pre-Frailty, Frailty, Diet, Dietary Fiber, Systemic Inflammatory Response
- Being tested
- Pectin, Whey protein
- Keywords
- Pectin, LM Pectin, Frailty, Pre-Frailty, Systemic inflammation, Dietary intervention, Gut microbiome
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PectinDietary 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 proteinOther
10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin.
| Study group | Role | What they receive |
|---|---|---|
| Pectin | Active comparator | 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour will be provided to participants for 4 weeks. Receives: Dietary Supplement: Pectin |
| Whey protein | Placebo comparator | 10g of whey protein with 10g of cocoa powder added as flavour will be provided to participants for 4 weeks. Receives: Other: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Changes in short chain fatty acids (SCFAs)
Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period.
Measured: 4 weeks
Secondary outcomes (10)
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.
Measured: 4 minutes
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
Measured: 4 minutes
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.
Measured: 4 minutes
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.
Measured: 4 minutes
Change in body mass index (BMI)
Change in BMI pre and post the 4-week intervention period.
Measured: 4 weeks
Change in waist-to-hip ratio (WHR)
Change in WHR pre and post the 4-week intervention period.
Measured: 4 weeks
Change in time up and go test (TUG)
Change in TUG pre and post the 4-week intervention period.
Measured: 4 weeks
Change in 30-second sit to stand test
Change in 30-second sit to stand test pre and post the 4-week intervention period.
Measured: 4 weeks
Change in Hospital Anxiety and Depression Score (HADS)
Change in anxiety score (min score 0, max 3 with higher score indicating higher anxiety like symptoms), and depression score (min 3, max 0 with lower the scores indicating higher depression like symptoms) measured pre and post the 4-week intervention.
Measured: 4 weeks
Change in 36-Item Short Form Survey (SF-36) Questionnaire
Change in SF-36 scores pre and post intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start10 Feb 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty at Older AdultsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Valdes, University of Nottingham
- Investigators
- Professor Ana Valdes, PhD student candidate, Principal investigator, University of NottinghamNoor K Al-Tameemi, PhD student candidate, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955975
- Sponsor's protocol ID
- FMHS 280-0924
- Acronym
- GEOFF
- Status last verified
- Jun 2025
- First submitted
- 24 Apr 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team will try their best to share statistical plan with other researchers
Publications
Al-Tameemi NK, Kouraki A, Kelly T, Grove JI, Rollins KE, Aithal GP, Valdes AM. The effect of pectin supplementation on geriatric individuals with frailty: a randomised placebo-controlled dietary intervention study. Geroscience. 2026 Sep 28. doi: 10.1007/s11357-026-02562-8. Online ahead of print.
PubMed 42803883
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT06955975
- Acronym / sponsor ID
- GEOFF / FMHS 280-0924
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled intervention
| Arm | Type | Receives |
|---|---|---|
| Pectin | Active comparator | Dietary Supplement: Pectin10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour will be provided to participants for 4 weeks. |
| Whey protein | Placebo comparator | Other: Whey protein10g of whey protein with 10g of cocoa powder added as flavour will be provided to participants for 4 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pectin10g 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. | Dietary supplement | Pectin |
| Whey protein10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin. | Other | Whey protein |
Primary outcome
Change in microbiome profile
Time frame: 4 weeks
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period.
Change in inflammatory profile
Time frame: 4 weeks
Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period.
Changes in short chain fatty acids (SCFAs)
Time frame: 4 weeks
Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period.
10 secondary outcomes
Change in systolic blood pressure (lying to standing) pre intervention
Time frame: 4 minutes
Change in systolic blood pressure (lying to standing) post intervention
Time frame: 4 minutes
Change in diastolic blood pressure (lying to standing) pre intervention
Time frame: 4 minutes
Change in diastolic blood pressure (lying to standing) post intervention
Time frame: 4 minutes
Change in body mass index (BMI)
Time frame: 4 weeks
Change in waist-to-hip ratio (WHR)
Time frame: 4 weeks
Change in time up and go test (TUG)
Time frame: 4 weeks
Change in 30-second sit to stand test
Time frame: 4 weeks
Change in Hospital Anxiety and Depression Score (HADS)
Time frame: 4 weeks
Change in 36-Item Short Form Survey (SF-36) Questionnaire
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 42803883Al-Tameemi NK, Kouraki A, Kelly T, Grove JI, Rollins KE, Aithal GP, Valdes AM. The effect of pectin supplementation on geriatric individuals with frailty: a randomised placebo-controlled dietary intervention study. Geroscience. 2026 Sep 28. doi: 10.1007/s11357-026-02562-8. Online ahead of print.
- Individual participant dataSharing planned: Undecided. The research team will try their best to share statistical plan with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noor K Al-Tameemi, PhD student candidate contact
Professor Ana Valdes, PhD student candidate principal investigator
University of Nottingham
Noor K Al-Tameemi, PhD student candidate study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectin and Whey protein in people with Frailty at Older Adults and Pre-Frailty, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noor K Al-Tameemi, PhD student candidate (0044 01158231149, noorkifahabdulhussein.al-tameemi@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome profile (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.