Pre-diabetesPreVegDietNCT06147323
Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients
A study testing Normal Healthy Diet and Seaweed Group in people with Pre-diabetes, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
The research area that focuses on the links between nutrition and health, nutrition and the immune system as well as nutrition-related public health interventions, which often falls into the gap between the agricultural and health domains. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Normal Healthy Diet and Seaweed Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Nov 2023to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 60 years, with
- Fasting blood glucose level of 5.6-6.9mmol/L or impaired HbA1c (HbA1c level of 5.7%-6.4%)
- Fasting blood glucose level below 5.6mmol/L or HbA1c level below 5.7%.
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
Who cannot join
- People with a current diagnosis or clinical history of T2DM
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems.
- People who are already participating in a weight loss programme
- People receiving drug treatment for pre-diabetes (eg, metformin)
- People with a history of long-term use of medicines known to influence glucose metabolism (eg, corticosteroids)
- People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
- People who take antibiotics or bacterial agents (Probiotics) within 1 month
- Pregnant women, women ready for pregnancy, and nursing mothers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: University of Roehampton
The research area that focuses on the links between nutrition and health, nutrition and the immune system as well as nutrition-related public health interventions, which often falls into the gap between the agricultural and health domains. The rationale of this project is to study the influence of beneficial diets on the immune system of pre-diabetic patients and its potential to counteract infections. A clinical, an in vitro (cell systems) and an in vivo (animal model) approach will be used to study the influence of a seaweed bioactive supplement and a diet rich in components from a Mediterranean diet on a Salmonella typhimurium infection in prediabetic subjects. At the end of this project, we will provide evidence on the potential of these nutritional interventions to counteract infection, which are of high relevance to the society to reduce the burden of type 2 diabetes (T2DM) and obesity. This research is part of an ongoing research project funded by the Research State Agency (Spain), Health Research Board (HRB, Ireland) and the Medical Research Council (MRC-UKRI, UK) via the NUTRIMMUNE' Grant of the Joint Programming Initiative a Healthy Diet for a Healthy Life (JPI-HDHL).
Read the detailed description
The aim of this study is to evaluate the effects of different diets on gut health, immune and metabolic markers, in individuals aged between 18-65 years who are defined as pre-diabetics and adults in general good health.
About 45 volunteers will take part in this study and they will then be randomly assigned a volunteer number and placed in one of three study group for a total of 12 weeks:
- Normal Healthy Diet group (N=15): Participants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/).
- Placebo group (N=15): Participants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow.
- Seaweed Group.: Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study.
At baseline (week 0), week 6, week 12 and week 16, volunteers will be required to visit the University of Roehampton to provide fasted blood, saliva, stool and first pass urine samples and have blood pressure, body fat and weight measured.
During the study period, they will be asked to complete some questionnaire to assess your gastrointestinal symptoms along with daily stool habits and diet habits.
- Conditions
- Pre-diabetes
- Being tested
- Normal Healthy Diet, Seaweed Group, Placebo Diet Group
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Healthy DietOther
Also called Eatwell diet Control
Participants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/).
Seaweed GroupDietary supplement
Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study.
Placebo Diet GroupOther
Participants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow.
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Diet group | Active comparator | Participants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/). Receives: Other: Normal Healthy Diet |
| Placebo Group | Placebo comparator | Participants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow. Receives: Other: Placebo Diet Group |
| Seaweed Group | Active comparator | Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study. Receives: Dietary Supplement: Seaweed Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose levels
To investigate the effects of dietary intervention on blood glucose levels of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in insulin sensitivity
To investigate the effects of dietary intervention on insulin levels of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in gut microbiome
To investigate the effects of dietary intervention on gut microbiome of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in pro and anti-inflammatory biomarkers
To investigate the effects of dietary intervention on immunity of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in metabolic profile
To investigate the effects of dietary intervention on metabolic signature of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in dietary habits
To investigate the effects of dietary intervention on dietary habits of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in blood pressure
To investigate the effects of dietary intervention on blood pressure of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Changes in quality of life
To investigate the effects of dietary intervention on quality of life of pre-diabetics
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start13 Nov 2023
- Primary completion17 Jul 2024
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, University College Cork
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- ADELE COSTABILE, Dr, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147323
- Sponsor's protocol ID
- LSC 23/388
- Acronym
- PreVegDiet
- Status last verified
- May 2026
- First submitted
- 14 Nov 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Roehampton
- ClinicalTrials.gov ID
- NCT06147323
- Acronym / sponsor ID
- PreVegDiet / LSC 23/388
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, University College Cork
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 27 Nov 2023 (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 research area that focuses on the links between nutrition and health, nutrition and the immune system as well as nutrition-related public health interventions, which often falls into the gap between the agricultural and health domains. The rationale of this project is to study the influence of beneficial diets on the immune system of pre-diabetic patients and its potential to counteract infections. A clinical, an in vitro (cell systems) and an in vivo (animal model) approach will be used to study the influence of a seaweed bioactive supplement and a diet rich in components from a Mediterranean diet on a Salmonella typhimurium infection in prediabetic subjects. At the end of this project, we will provide evidence on the potential of these nutritional interventions to counteract infection, which are of high relevance to the society to reduce the burden of type 2 diabetes (T2DM) and obesity. This research is part of an ongoing research project funded by the Research State Agency (Spain), Health Research Board (HRB, Ireland) and the Medical Research Council (MRC-UKRI, UK) via the NUTRIMMUNE' Grant of the Joint Programming Initiative a Healthy Diet for a Healthy Life (JPI-HDHL).
Detailed description
The aim of this study is to evaluate the effects of different diets on gut health, immune and metabolic markers, in individuals aged between 18-65 years who are defined as pre-diabetics and adults in general good health.
About 45 volunteers will take part in this study and they will then be randomly assigned a volunteer number and placed in one of three study group for a total of 12 weeks:
- Normal Healthy Diet group (N=15): Participants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/).
- Placebo group (N=15): Participants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow.
- Seaweed Group.: Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study.
At baseline (week 0), week 6, week 12 and week 16, volunteers will be required to visit the University of Roehampton to provide fasted blood, saliva, stool and first pass urine samples and have blood pressure, body fat and weight measured.
During the study period, they will be asked to complete some questionnaire to assess your gastrointestinal symptoms along with daily stool habits and diet habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Diet group | Active comparator | Other: Normal Healthy DietParticipants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/). |
| Placebo Group | Placebo comparator | Other: Placebo Diet GroupParticipants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow. |
| Seaweed Group | Active comparator | Dietary Supplement: Seaweed GroupParticipants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged between 18 and 60 years, with
- Fasting blood glucose level of 5.6-6.9mmol/L or impaired HbA1c (HbA1c level of 5.7%-6.4%)
- Fasting blood glucose level below 5.6mmol/L or HbA1c level below 5.7%.
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
Key exclusion criteria (8 listed)
- People with a current diagnosis or clinical history of T2DM
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems.
- People who are already participating in a weight loss programme
- People receiving drug treatment for pre-diabetes (eg, metformin)
- People with a history of long-term use of medicines known to influence glucose metabolism (eg, corticosteroids)
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 |
|---|---|---|
| Normal Healthy DietAlso: Eatwell diet ControlParticipants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/). | Other | Normal Healthy Diet group |
| Seaweed GroupParticipants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study. | Dietary supplement | Seaweed Group |
| Placebo Diet GroupParticipants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow. | Other | Placebo Group |
Primary outcome
Changes in blood glucose levels
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on blood glucose levels of pre-diabetics
Changes in insulin sensitivity
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on insulin levels of pre-diabetics
Changes in gut microbiome
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on gut microbiome of pre-diabetics
Changes in pro and anti-inflammatory biomarkers
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on immunity of pre-diabetics
Changes in metabolic profile
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on metabolic signature of pre-diabetics
Changes in dietary habits
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on dietary habits of pre-diabetics
Changes in blood pressure
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on blood pressure of pre-diabetics
Changes in quality of life
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
To investigate the effects of dietary intervention on quality of life of pre-diabetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Studies websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
ADELE COSTABILE, Dr study director
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Healthy Diet and Seaweed Group in people with Pre-diabetes, run by University of Roehampton 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 7 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood glucose levels (time frame: Changes from baseline to 6 and 12 weeks of the intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.