PrediabetesBASA-ONCT05329610
β-alanine Supplementation in Adults With Overweight/Obesity
A study testing Beta-alanine in people with Prediabetes and Hyperglycemia, run by Nottingham Trent University at 2 sites in United Kingdom.
Trial summary
The study will investigate the safety, feasibility, and efficacy of beta-alanine supplementation in adults with overweight or obesity. Beta-alanine is a widely used dietary supplement that can increase the amount of carnosine in skeletal muscle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes, Hyperglycemia, Overweight or Obesity
- What is being tested?
- Beta-alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Apr 2022to 20 Jul 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 75 years
- Body Mass Index (BMI) ≥25 to <40 kg/m2
- Able to provide informed consent
Who cannot join
- Weight loss or gain ≥5 kg in the prior 6 months
- Current participation in another clinical research trial
- Substance abuse, presence of an eating disorder or purging behaviour
- Known mental health illness requiring active treatment
- Known cognitive impairment
- Inability to understand conversational English
Show all 11Show fewer
- Presence of type-1 or type-2 diabetes mellitus
- Use of carnosine or β-alanine supplements in the prior 6 months
- Current breastfeeding, pregnancy, or consideration of pregnancy
- Known comorbidities which may impact on study aims (e.g., cancer, heart failure, or chronic kidney disease) or measurement of study outcomes (e.g., sickle cell anaemia or previously known haemoglobinopathy)
- Use of weight loss or glucose lowering drugs (e.g., orlistat, thyroxine, metformin, insulin, glucagon-like-peptide-1 analogues), long-term corticosteroids, or other drugs which may impact on measurement of study outcomes
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Aston University
Birmingham, West Midlands, B4 7ET
Nottingham Trent University
Nottingham, Nottinghamshire, NG11 8NS
About this study
Official title: β-alanine Supplementation in Adults With Overweight or Obesity (BASA-O): A Randomised Controlled Feasibility Trial
The study will investigate the safety, feasibility, and efficacy of beta-alanine supplementation in adults with overweight or obesity. Beta-alanine is a widely used dietary supplement that can increase the amount of carnosine in skeletal muscle. Both carnosine and beta-alanine occur naturally in animal food products and previous research shows that supplementation with beta-alanine leads to an improvement in exercise performance; more recently, the present investigators have shown that increasing carnosine can also help to improve cardiometabolic health, detoxify skeletal muscle, and improve glucose (sugar) uptake into muscle cells.
The investigators will recruit 30 participants (15 per arm) with overweight or obesity who meet the study criteria (this accounts for up to 20% attrition - a minimum of 12 participants per arm). Those who are eligible will be required to receive three short telephone calls and attend three laboratory sessions. Participants will be randomised to receive either beta-alanine or placebo (an inactive sugar pill) for the 3-month study period.
To see whether beta-alanine supplementation is feasible in this population the investigators will measure recruitment, adherence (how well people can stick to the supplement regime), the number and nature of side effects, and blinding to the intervention. Markers of cardiac function, glycaemic control, and metabolic health will also be explored. All measurements will take place before and after a 3-month supplementation period. This will provide us with novel information of the role of beta-alanine and carnosine in cardiometabolic health; and will aid in the planning of a larger randomised controlled trial to assess the efficacy of beta-alanine supplementation as a therapeutic strategy.
Read the detailed description
Overweight and obesity are major public health problems. Recent estimates show that 64.3% of people in the UK are living with overweight or obesity; this is projected to increase to 71% by 2040, which equates to approx. 42.2 million people (Cancer Research UK, 2022). Overweight and obesity are characterised by excess amounts of adiposity and systemic, chronic, low-grade inflammation, which is associated with a range of metabolic disorders including dyslipidaemia, hypertension, and hyperglycaemia (Calder et al., 2011). This confers an increased risk of developing prediabetes, type-2 diabetes, and cardiovascular disease, as well as associated microvascular complications such as retinopathy, neuropathy, and nephropathy (Brannick et al., 2016). Lifestyle interventions can help delay or prevent the progression of overweight or obesity, thereby reducing morbidity (Lin et al., 2017; Wing et al., 2021). Such interventions, however, can be challenging to implement and a lack of long-term adherence can limit their effectiveness (Fappa et al., 2008). It is therefore important to develop low-cost, novel adjunct therapies to improve cardiometabolic health and help delay or prevent disease progression.
The multifunctional dipeptide carnosine has emerged as a candidate for improving glycaemic control and cardiometabolic health. A recent meta-analysis showed that supplementation with carnosine, or its rate-limiting precursor β-alanine, reduces fasting glucose and HbA1c in humans and rodents. Work from our Research Group shows that treatment with carnosine decreases highly toxic lipid peroxidation products in skeletal muscle cells, leading to an increase in insulin-stimulated glucose uptake under glucolipotoxic conditions. A similar role occurs in vivo, where supplementation with β-alanine leads to greater formation of carnosine-adducts in post-exercise skeletal muscle samples. Given that skeletal muscle insulin resistance is a key component of prediabetes and type 2 diabetes, and reactive aldehydes can directly interfere with insulin signalling, carnosine may exert its therapeutic actions in skeletal muscle. There is also emerging evidence that carnosine, and other histidine-containing dipeptides (HCDs), play an important role in Ca2+ handling and excitation-contraction coupling in cardiac muscle, which may have implications for cardiovascular health. A limitation of existing studies is that the low carnosine dose used is likely to have only a modest effect on tissue carnosine content. Supplementation with β-alanine, however, can increase skeletal muscle carnosine content by 60-80% in 4-10 weeks, but it has not yet been trialled in adults with overweight or obesity.
Please note: a change was made to the study eligibility criteria, which was approved by the UK Health Research Authority Research Ethics Committee on 01/09/2022.
- Conditions
- Prediabetes, Hyperglycemia, Overweight or Obesity
- Being tested
- Beta-alanine, Placebo
- Keywords
- Prediabetes, Hyperglycemia, Carnosine, Overweight, Obesity
- Medical subject headings
- Prediabetic State, Hyperglycemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-alanineDietary supplement
Slow-release beta-alanine.
PlaceboDietary supplement
Taste and appearance-matched placebo (tapioca starch).
| Study group | Role | What they receive |
|---|---|---|
| Beta-alanine | Experimental | Slow-release beta-alanine (Natural Alternatives International, Carlsbad, CA, USA). Dose: 4.8 grams per day for 3-months (potential total intake of 432 g beta-alanine). The daily intake will be split into four doses of 2 x 600 mg. Participants will be instructed to consume each dose alongside their main daily meals (e.g., breakfast, lunch, and dinner) and before bed. Receives: Dietary Supplement: Beta-alanine |
| Placebo | Placebo comparator | Taste and appearance-matched placebo (tapioca starch) (Natural Alternatives International, Carlsbad, CA, USA). Doses equivalent to the experimental arm. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the intervention
Probability that a randomised participant receives the assigned intervention.
Measured: 3-months (endpoint)
Secondary outcomes (4)
Recruitment
Probability an eligible participant consents and is randomised.
Measured: Baseline
Attrition rate
Probability that a randomised participant is evaluated for baseline and follow-up.
Measured: 3-months (endpoint)
Side effects
Data collected using the GASE questionnaire.
Measured: Baseline and 3-months (endpoint)
Blinding to the intervention
Assessed using the -1, 0, +1 scale (Bang et al., 2004).
Measured: 3-months (endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start5 Apr 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, randomised, placebo-controlled, parallel group, feasibility trial. The allocation ratio of treatment to placebo will be 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Aston University
- Responsible party
- Principal investigator, Joseph J Matthews, Nottingham Trent University
- Investigators
- Craig Sale, PhD, Principal investigator, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329610
- Sponsor's protocol ID
- 676
- Acronym
- BASA-O
- Status last verified
- Aug 2023
- First submitted
- 21 Oct 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data will be deidentified and preserved for at least 10 years in an open-access data repository (e.g., Zenodo). This will allow anyone else (including other researchers and the general public) to also use the deidentified data for relevant analyses.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- β-alanine Supplementation in Adults With Overweight or Obesity (BASA-O): A Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05329610
- Acronym / sponsor ID
- BASA-O / 676
- Conditions
- Prediabetes, Hyperglycemia, Overweight or Obesity
- Keywords
- Prediabetes, Hyperglycemia, Carnosine, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Aston University
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 15 Apr 2022 (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 will investigate the safety, feasibility, and efficacy of beta-alanine supplementation in adults with overweight or obesity. Beta-alanine is a widely used dietary supplement that can increase the amount of carnosine in skeletal muscle. Both carnosine and beta-alanine occur naturally in animal food products and previous research shows that supplementation with beta-alanine leads to an improvement in exercise performance; more recently, the present investigators have shown that increasing carnosine can also help to improve cardiometabolic health, detoxify skeletal muscle, and improve glucose (sugar) uptake into muscle cells.
The investigators will recruit 30 participants (15 per arm) with overweight or obesity who meet the study criteria (this accounts for up to 20% attrition - a minimum of 12 participants per arm). Those who are eligible will be required to receive three short telephone calls and attend three laboratory sessions. Participants will be randomised to receive either beta-alanine or placebo (an inactive sugar pill) for the 3-month study period.
To see whether beta-alanine supplementation is feasible in this population the investigators will measure recruitment, adherence (how well people can stick to the supplement regime), the number and nature of side effects, and blinding to the intervention. Markers of cardiac function, glycaemic control, and metabolic health will also be explored. All measurements will take place before and after a 3-month supplementation period. This will provide us with novel information of the role of beta-alanine and carnosine in cardiometabolic health; and will aid in the planning of a larger randomised controlled trial to assess the efficacy of beta-alanine supplementation as a therapeutic strategy.
Detailed description
Overweight and obesity are major public health problems. Recent estimates show that 64.3% of people in the UK are living with overweight or obesity; this is projected to increase to 71% by 2040, which equates to approx. 42.2 million people (Cancer Research UK, 2022). Overweight and obesity are characterised by excess amounts of adiposity and systemic, chronic, low-grade inflammation, which is associated with a range of metabolic disorders including dyslipidaemia, hypertension, and hyperglycaemia (Calder et al., 2011). This confers an increased risk of developing prediabetes, type-2 diabetes, and cardiovascular disease, as well as associated microvascular complications such as retinopathy, neuropathy, and nephropathy (Brannick et al., 2016). Lifestyle interventions can help delay or prevent the progression of overweight or obesity, thereby reducing morbidity (Lin et al., 2017; Wing et al., 2021). Such interventions, however, can be challenging to implement and a lack of long-term adherence can limit their effectiveness (Fappa et al., 2008). It is therefore important to develop low-cost, novel adjunct therapies to improve cardiometabolic health and help delay or prevent disease progression.
The multifunctional dipeptide carnosine has emerged as a candidate for improving glycaemic control and cardiometabolic health. A recent meta-analysis showed that supplementation with carnosine, or its rate-limiting precursor β-alanine, reduces fasting glucose and HbA1c in humans and rodents. Work from our Research Group shows that treatment with carnosine decreases highly toxic lipid peroxidation products in skeletal muscle cells, leading to an increase in insulin-stimulated glucose uptake under glucolipotoxic conditions. A similar role occurs in vivo, where supplementation with β-alanine leads to greater formation of carnosine-adducts in post-exercise skeletal muscle samples. Given that skeletal muscle insulin resistance is a key component of prediabetes and type 2 diabetes, and reactive aldehydes can directly interfere with insulin signalling, carnosine may exert its therapeutic actions in skeletal muscle. There is also emerging evidence that carnosine, and other histidine-containing dipeptides (HCDs), play an important role in Ca2+ handling and excitation-contraction coupling in cardiac muscle, which may have implications for cardiovascular health. A limitation of existing studies is that the low carnosine dose used is likely to have only a modest effect on tissue carnosine content. Supplementation with β-alanine, however, can increase skeletal muscle carnosine content by 60-80% in 4-10 weeks, but it has not yet been trialled in adults with overweight or obesity.
Please note: a change was made to the study eligibility criteria, which was approved by the UK Health Research Authority Research Ethics Committee on 01/09/2022.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded, randomised, placebo-controlled, parallel group, feasibility trial. The allocation ratio of treatment to placebo will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| Beta-alanine | Experimental | Dietary Supplement: Beta-alanineSlow-release beta-alanine (Natural Alternatives International, Carlsbad, CA, USA). Dose: 4.8 grams per day for 3-months (potential total intake of 432 g beta-alanine). The daily intake will be split into four doses of 2 x 600 mg. Participants will be instructed to consume each dose alongside their main daily meals (e.g., breakfast, lunch, and dinner) and before bed. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTaste and appearance-matched placebo (tapioca starch) (Natural Alternatives International, Carlsbad, CA, USA). Doses equivalent to the experimental arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged 18 to 75 years
- Body Mass Index (BMI) ≥25 to <40 kg/m2
- Able to provide informed consent
Key exclusion criteria (11 listed)
- Weight loss or gain ≥5 kg in the prior 6 months
- Current participation in another clinical research trial
- Substance abuse, presence of an eating disorder or purging behaviour
- Known mental health illness requiring active treatment
- Known cognitive impairment
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 |
|---|---|---|
| Beta-alanineSlow-release beta-alanine. | Dietary supplement | Beta-alanine |
| PlaceboTaste and appearance-matched placebo (tapioca starch). | Dietary supplement | Placebo |
Primary outcome
Adherence to the intervention
Time frame: 3-months (endpoint)
Probability that a randomised participant receives the assigned intervention.
4 secondary outcomes
Recruitment
Time frame: Baseline
Attrition rate
Time frame: 3-months (endpoint)
Side effects
Time frame: Baseline and 3-months (endpoint)
Blinding to the intervention
Time frame: 3-months (endpoint)
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 1 Sep 2023.
- Individual participant dataSharing planned: No. Research data will be deidentified and preserved for at least 10 years in an open-access data repository (e.g., Zenodo). This will allow anyone else (including other researchers and the general public) to also use the deidentified data for relevant analyses.
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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.
Craig Sale, PhD principal investigator
Nottingham Trent University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-alanine in people with Prediabetes and Hyperglycemia, run by Nottingham Trent University at 2 sites 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 11 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adherence to the intervention (time frame: 3-months (endpoint)). 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 1 Sep 2023.