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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Whey protein | Placebo Comparator | 10g of whey protein with 10g of cocoa powder added as flavour will be provided to participants for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 minutes |
| Change in systolic blood pressure (lying to standing) post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noor K Al-Tameemi, PhD student candidate | Contact | 0044 01158231149 | noorkifahabdulhussein.al-tameemi@nottingham.ac.uk | |
| Professor Ana Valdes | Contact | 0044 0115 969 1169 | Ana.Valdes@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Professor Ana Valdes, PhD student candidate | University of Nottingham | Principal Investigator |
| Noor K Al-Tameemi, PhD student candidate | University of Nottingham | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Recruiting | Nottingham | Nottingham | NG7 2UH | United Kingdom |
The research team will try their best to share statistical plan with other researchers
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Controlled intervention
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Double-blinded.
| Whey protein | Other | 10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin. |
|
Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit |
| 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. | 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. | 4 minutes |
| Change in body mass index (BMI) | Change in BMI pre and post the 4-week intervention period. | 4 weeks |
| Change in waist-to-hip ratio (WHR) | Change in WHR pre and post the 4-week intervention period. | 4 weeks |
| Change in time up and go test (TUG) | Change in TUG pre and post the 4-week intervention period. | 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. | 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. | 4 weeks |
| Change in 36-Item Short Form Survey (SF-36) Questionnaire | Change in SF-36 scores pre and post intervention. | 4 weeks |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010368 | Pectins |
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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