An interventional study of Inulin Fibre supplement and Maltodextrin (Placebo) in Osteoarthritis, Knee, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by University of Nottingham · Not applicable, Interventional, and Basic science
This is a 2x2 factorial design randomised controlled trial in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm. The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents. N= 117. 2x2 intervention with individuals per block: placebo (n=27), diet only (n=26), exercise only (n=40), diet + exercise (n=24)
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 117 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
The participants in the placebo/control arm will be required to take 10g of maltodextrin for the same period of 6 weeks.
Dietary Supplement: Maltodextrin (Placebo)
The participants in the dietary intervention arm will be required to take 20g of inulin for a period of 6 weeks.
Dietary Supplement: Inulin Fibre supplement
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises. The intervention also includes educational sessions integrated into the programme covering the basics of OA, its treatment, self-managing symptoms of OA and the benefits of maintaining a healthy lifestyle. The exercise intervention focuses on core stability and performance, neuromuscular leg strengthening and balance enhancement.
Behavioral: Exercise
The participants in this arm will be required to take 20g of inulin for a period of 6 weeks and doing exercise at the same time.
Dietary Supplement: Inulin Fibre supplement · Behavioral: Exercise
20g/ day. Inulin is easily dissolvable in liquid and can be incorporated into the usual diet - by adding to water, juice, smoothies, cereal, yogurt etc.
10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises.
Change in Numerical Rate Score (NRS) for Pain
The Numerical Rate Score (NRS) will be used to assess the changes in the level of pain in response to the intervention between baseline and follow-up. Participants reported their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 the worst pain imaginable.
Time frame: Baseline and 6 weeks
Change in Functional Outcome 30-seconds Sit-to-stand (30CST)
Measures how many times a participant can rise from a chair to a full standing position in 30 seconds.
Time frame: Baseline and 6 weeks
Change in Functional Outcome Timed-up and go (TUG)
Time in seconds to stand up, walk 3m, return, and sit. Average of 3 trials at baseline and follow-up (at the end of 6 weeks).
Time frame: Baseline and 6 weeks
Change in Functional Outcome Grip Strength
Measured with dynamometer; average of 3 trials on dominant hand in seated position with participant applying as much grip pressure as possible on the dynamometer. The maximum reading (kg) in taken for each repetition.
Time frame: Baseline and 6 weeks
Change in Pain Sensitisation Outcome Temporal Summation (TS)
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality temporal summation (TS). TS assesses sensitivity to sharpness by applying a brief "pinprick" stimulus (256 mN Pinprick; MRC-Systems, Heidelberg, Germany) to the skin with higher ratings potentially suggesting increased spinal cord pain sensitivity. A single stimulus was applied to the rectus femoris (5cm above the mid-point of the patella of the most painful knee), followed by 10 repetitive stimuli at 1/s. Participants rated pain/sharpness intensity on a 0-10 Visual Analogue Scale after both the single and the average of the repeated stimuli. Each test was performed twice, with a 2-minute break between repetitions and the average was taken.
Time frame: Baseline and 6 weeks
Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superolateral Patella Site
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: quadricep (2cm above superolateral edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
Time frame: Baseline and 6 weeks
Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superomedial Patella Site
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: quadricep (2cm above superomedial edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
Time frame: Baseline and 6 weeks
Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Medial Joint Line Site
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from abeline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at the anatomical position: medial joint line (3cm medially from medial edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
Time frame: Baseline and 6 weeks
Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Tibialis Anterior Muscle Site
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: tibialis anterior (5 cm distal and 1 cm lateral to the tibial tuberosity). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
Time frame: Baseline and 6 weeks
Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Brachioradialis Muscle Site
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: brachioradialis (5 cm medial and distal to the lateral epicondyle) on the arm opposite the painful knee. PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the arm opposite the painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
Time frame: Baseline and 6 weeks
Change in Short Chain Fatty Acid Butyric Acid
Change in serum levels of short-chain fatty acid (SCFA) butyric acid in response to the interventions. SCFA levels in serum will be measured using mass spectrometry.
Time frame: Baseline and 6 weeks
Change in Short Chain Fatty Acid Acetic Acid
Change in serum levels of short-chain fatty acid (SCFA) acetic acid in response to theinterventions. SCFA levels in serum will be measured using mass spectrometry.
Time frame: Baseline and 6 weeks
Change in Inflammatory Protein Interleukin-6 (IL-6) Levels
Change in Interleukin-6 (IL-6) inflammatory protein levels measured with the Olink for a subset of individuals. For Olink cytokine assay panels data is reported in either Normalized Protein eXpression units (NPX) units or absolute concentration units (pg/mL), with the lower limit of detection typically below 1 pg/mL for most assays.
Time frame: Baseline and 6 weeks
Change in Tumor Necrosis Factor (TNF) Inflammatory Protein Levels
Change in Tumor Necrosis Factor (TNF) inflammatory protein levels measured with the Olink for a subset of individuals. For Olink cytokine assay panels data is reported in either Normalized Protein eXpression units (NPX) units or absolute concentration units (pg/mL), with the lower limit of detection typically below 1 pg/mL for most assays.
Time frame: Baseline and 6 weeks
Change in Inflammatory Protein Interferon Gamma (IFN-γ) Levels
Change in Interferon gamma (IFN-γ) inflammatory protein levels measured with the Olink for a subset of individuals. For Olink cytokine assay panels data is reported in either Normalized Protein eXpression units (NPX) units or absolute concentration units (pg/mL), with the lower limit of detection typically below 1 pg/mL for most assays.
Time frame: Baseline and 6 weeks
Changes in Gut Microbiome (Shannon Diversity Index)
The gut microbiome will be measured with shotgun metagenomic sequencing of stool samples and the Shannon Diversity Index will be calculated. The Shannon Diversity Index assesses both the richness (number of different species) and evenness (distribution of individuals among species) within the gut microbiome. A higher Shannon index indicates a more diverse microbiome, while a lower index suggests less diversity.
Time frame: Baseline and 6 weeks
Change in Serum Endocannabinoid Anandamide (AEA) Levels
Serum levels of Endocannabinoid Anandamide (AEA) will be measured using mass spectrometry in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of Endocannabinoid Anandamide (AEA) in response to the intervention.
Time frame: Baseline and 6 weeks
Change in Serum 2-arachidonoylglycerol (2-AG) Endocannabinoid Levels
Serum levels of 2-arachidonoylglycerol (2-AG) Endocannabinoid will be measured using mass spectrometry in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of 2-arachidonoylglycerol (2-AG) Endocannabinoid in response to the intervention.
Time frame: Baseline and 6 weeks
Changes in Calcium Voltage-gated Channel Subunit alpha1 B Gene Expression Levels Using Transcriptomics on a Subset of Individuals
Transcriptomics will be measured using RNA sequencing of blood samples collected at baseline and at follow-up (at the end of six weeks). RNA was extracted from whole blood, and sequencing libraries were prepared and analysed using standard RNA-seq pipelines.
Time frame: Baseline and 6 weeks
Changes in Solute Carrier Family 12 Member 5 Gene Expression Levels Using Transcriptomics on a Subset of Individuals
Transcriptomics will be measured using RNA sequencing of blood samples collected at baseline and at follow-up (at the end of six weeks). RNA was extracted from whole blood, and sequencing libraries were prepared and analysed using standard RNA-seq pipelines.
Time frame: Baseline and 6 weeks
Changes in Sodium Voltage-gated Channel Alpha Subunit 11 Gene Expression Levels Using Transcriptomics on a Subset of Individuals
Transcriptomics will be measured using RNA sequencing of blood samples collected atbaseline and at follow-up (at the end of six weeks). RNA was extracted from whole blood,and sequencing libraries were prepared and analysed using standard RNA-seq pipelines.
Time frame: Baseline and 6 weeks
| Milestone | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Started | 27 | 26 | 40 | 24 |
| Completed | 27 | 26 | 40 | 24 |
| Not completed | 0 | 0 | 0 | 0 |
The Numerical Rate Score (NRS) will be used to assess the changes in the level of pain in response to the intervention between baseline and follow-up. Participants reported their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 the worst pain imaginable.
| units on a scale | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Numerical Rate Score (NRS) for Pain | 0.67 ± 2.49 | -0.73 ± 2.32 | -1.25 ± 2.69 | -1.21 ± 1.76 |
Measures how many times a participant can rise from a chair to a full standing position in 30 seconds.
| stands | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Functional Outcome 30-seconds Sit-to-stand (30CST) | 1.23 ± 1.67 | 2.12 ± 3.02 | 2.54 ± 3.38 | 3.21 ± 5.37 |
Time in seconds to stand up, walk 3m, return, and sit. Average of 3 trials at baseline and follow-up (at the end of 6 weeks).
| seconds | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Functional Outcome Timed-up and go (TUG) | -0.43 ± 1.06 | -1.19 ± 2.19 | -2.07 ± 5.82 | -0.78 ± 1.14 |
Measured with dynamometer; average of 3 trials on dominant hand in seated position with participant applying as much grip pressure as possible on the dynamometer. The maximum reading (kg) in taken for each repetition.
| kg | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Functional Outcome Grip Strength | -1.43 ± 6.44 | 0.76 ± 3.42 | 0.02 ± 5.62 | 0.76 ± 3.42 |
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality temporal summation (TS). TS assesses sensitivity to sharpness by applying a brief "pinprick" stimulus (256 mN Pinprick; MRC-Systems, Heidelberg, Germany) to the skin with higher ratings potentially suggesting increased spinal cord pain sensitivity. A single stimulus was applied to the rectus femoris (5cm above the mid-point of the patella of the most painful knee), followed by 10 repetitive stimuli at 1/s. Participants rated pain/sharpness intensity on a 0-10 Visual Analogue Scale after both the single and the average of the repeated stimuli. Each test was performed twice, with a 2-minute break between repetitions and the average was taken.
| units on a scale | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Pain Sensitisation Outcome Temporal Summation (TS) | 0.30 ± 1.66 | -0.20 ± 1.52 | -0.17 ± 1.62 | -0.63 ± 2.01 |
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: quadricep (2cm above superolateral edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
| kPa | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superolateral Patella Site | -87.19 ± 103.53 | -29.89 ± 175.35 | -92.74 ± 159.03 | -39.22 ± 240.27 |
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: quadricep (2cm above superomedial edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
| kPa | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superomedial Patella Site | -46.73 ± 137.77 | -25.33 ± 122.58 | -41.25 ± 126.96 | -22.28 ± 131.10 |
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from abeline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at the anatomical position: medial joint line (3cm medially from medial edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
| kPa | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Medial Joint Line Site | -54.54 ± 132.90 | -31.72 ± 132.51 | -10.91 ± 149.56 | -24.02 ± 160.48 |
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: tibialis anterior (5 cm distal and 1 cm lateral to the tibial tuberosity). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
| kPa | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Tibialis Anterior Muscle Site | -47.36 ± 160.31 | -17.57 ± 161.22 | -7.74 ± 122.59 | -20.66 ± 180.73 |
Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: brachioradialis (5 cm medial and distal to the lateral epicondyle) on the arm opposite the painful knee. PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the arm opposite the painful knee, with lower PPT threshold suggestive of increased pain sensitivity.
| kPa | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Brachioradialis Muscle Site | -27.77 ± 107.82 | -69.33 ± 119.04 | -37.31 ± 95.64 | -25.75 ± 150.32 |
Change in serum levels of short-chain fatty acid (SCFA) butyric acid in response to the interventions. SCFA levels in serum will be measured using mass spectrometry.
| ng/ml | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Short Chain Fatty Acid Butyric Acid | -36.67 ± 1082.93 | 345.61 ± 434.30 | -233.17 ± 991.08 | 769.14 ± 3413.58 |
Change in serum levels of short-chain fatty acid (SCFA) acetic acid in response to theinterventions. SCFA levels in serum will be measured using mass spectrometry.
| ng/ml | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Short Chain Fatty Acid Acetic Acid | -869.59 ± 3744.05 | 306.32 ± 1406.99 | -1081.01 ± 3561.43 | 110.37 ± 3334.09 |
Change in Interleukin-6 (IL-6) inflammatory protein levels measured with the Olink for a subset of individuals. For Olink cytokine assay panels data is reported in either Normalized Protein eXpression units (NPX) units or absolute concentration units (pg/mL), with the lower limit of detection typically below 1 pg/mL for most assays.
| pg/mL | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Inflammatory Protein Interleukin-6 (IL-6) Levels | -1.85 ± 2.45 | -0.70 ± 2.12 | -0.25 ± 0.78 | -0.12 ± 1.92 |
Change in Tumor Necrosis Factor (TNF) inflammatory protein levels measured with the Olink for a subset of individuals. For Olink cytokine assay panels data is reported in either Normalized Protein eXpression units (NPX) units or absolute concentration units (pg/mL), with the lower limit of detection typically below 1 pg/mL for most assays.
| pg/mL | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Tumor Necrosis Factor (TNF) Inflammatory Protein Levels | -0.52 ± 1.43 | -0.72 ± 1.92 | -0.39 ± 0.80 | -0.34 ± 1.78 |
Change in Interferon gamma (IFN-γ) inflammatory protein levels measured with the Olink for a subset of individuals. For Olink cytokine assay panels data is reported in either Normalized Protein eXpression units (NPX) units or absolute concentration units (pg/mL), with the lower limit of detection typically below 1 pg/mL for most assays.
| pg/mL | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Inflammatory Protein Interferon Gamma (IFN-γ) Levels | 0.32 ± 1.72 | 0.04 ± 2.56 | -0.72 ± 1.25 | -0.36 ± 2.56 |
The gut microbiome will be measured with shotgun metagenomic sequencing of stool samples and the Shannon Diversity Index will be calculated. The Shannon Diversity Index assesses both the richness (number of different species) and evenness (distribution of individuals among species) within the gut microbiome. A higher Shannon index indicates a more diverse microbiome, while a lower index suggests less diversity.
| index | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Changes in Gut Microbiome (Shannon Diversity Index) | 0.01 ± 0.26 | -0.07 ± 0.26 | -0.09 ± 0.31 | -0.08 ± 0.33 |
Serum levels of Endocannabinoid Anandamide (AEA) will be measured using mass spectrometry in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of Endocannabinoid Anandamide (AEA) in response to the intervention.
| nM | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Serum Endocannabinoid Anandamide (AEA) Levels | 0.32 ± 0.82 | 0.05 ± 0.66 | 0.05 ± 0.70 | 0.31 ± 0.77 |
Serum levels of 2-arachidonoylglycerol (2-AG) Endocannabinoid will be measured using mass spectrometry in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of 2-arachidonoylglycerol (2-AG) Endocannabinoid in response to the intervention.
| nM | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Change in Serum 2-arachidonoylglycerol (2-AG) Endocannabinoid Levels | 35.45 ± 72.07 | 6.28 ± 44.17 | 37.58 ± 78.17 | 16.83 ± 79.10 |
Transcriptomics will be measured using RNA sequencing of blood samples collected at baseline and at follow-up (at the end of six weeks). RNA was extracted from whole blood, and sequencing libraries were prepared and analysed using standard RNA-seq pipelines.
| fold change | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|
| Changes in Calcium Voltage-gated Channel Subunit alpha1 B Gene Expression Levels Using Transcriptomics on a Subset of Individuals | 26.37 ± 79.60 | 49.50 ± 140.48 |
Transcriptomics will be measured using RNA sequencing of blood samples collected at baseline and at follow-up (at the end of six weeks). RNA was extracted from whole blood, and sequencing libraries were prepared and analysed using standard RNA-seq pipelines.
| fold change | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|
| Changes in Solute Carrier Family 12 Member 5 Gene Expression Levels Using Transcriptomics on a Subset of Individuals | 14.02 ± 41.60 | 20.75 ± 59.51 |
Transcriptomics will be measured using RNA sequencing of blood samples collected atbaseline and at follow-up (at the end of six weeks). RNA was extracted from whole blood,and sequencing libraries were prepared and analysed using standard RNA-seq pipelines.
| fold change | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|
| Changes in Sodium Voltage-gated Channel Alpha Subunit 11 Gene Expression Levels Using Transcriptomics on a Subset of Individuals | 12.26 ± 33.70 | 31.97 ± 90.21 |
Collected over Day 1 through Day 42 (daily assessments, 7 days/week). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Arm | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Diet Only Arm | 0/26 (0%) | 0/26 (0%) | 10/26 (38.5%) |
| Exercise Only Arm | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Diet + Exercise Intervention Arm | 0/24 (0%) | 0/24 (0%) | 13/24 (54.2%) |
| Event | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm |
|---|---|---|---|---|
| Wind and bloatingGastrointestinal disorders | 0/27 | 10/26 | 0/40 | 13/24 |
A completers analysis was conducted using the participant numbers shown below.
| Age, Continuous(Years) | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm | Total |
|---|---|---|---|---|---|
| Mean | 69.59 ± 6.41 | 66.54 ± 11.39 | 67.75 ± 10.22 | 66.71 ± 8.44 | 67.69 ± 9.48 |
| Sex: Female, Male(Participants) | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm | Total |
|---|---|---|---|---|---|
| Female | 14 | 14 | 26 | 14 | 68 |
| Male | 13 | 12 | 14 | 10 | 49 |
| Race and Ethnicity Not Collected(Participants) | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Body mass index(kg/m2) | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm | Total |
|---|---|---|---|---|---|
| Mean | 29.60 ± 4.65 | 30.15 ± 3.75 | 29.00 ± 7.15 | 29.60 ± 4.65 | 29.48 ± 5.32 |
| Pain Numerical Rating Scale(units on a scale) | Placebo Arm | Diet Only Arm | Exercise Only Arm | Diet + Exercise Intervention Arm | Total |
|---|---|---|---|---|---|
| Mean | 3.52 ± 2.77 | 4.06 ± 2.85 | 4.21 ± 2.88 | 3.92 ± 1.75 | 3.96 ± 2.67 |
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University of Nottingham