β-alanine Supplementation in Prediabetes

  • STATUS
    Recruiting
  • End date
    Aug 30, 2023
  • participants needed
    30
  • sponsor
    Nottingham Trent University
Updated on 30 April 2022
body mass index
fasting
hemoglobin a1c
plasma glucose
sugars

Summary

The study will investigate the safety, feasibility, and efficacy of beta-alanine supplementation in adults with prediabetes. 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 detoxify skeletal muscle and improve glucose (sugar) uptake into muscle cells.

The investigators will recruit 30 participants (15 per arm) with prediabetes who meet the study criteria (this accounts for up to 25% 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 prediabetes; and will aid in the planning of a larger randomised controlled trial to assess the efficacy of beta-alanine supplementation as a therapeutic strategy.

Description

Diabetes is a major public health problem. Recent estimates show that 4.8 million people in the UK are living with diabetes, which is expected to rise to 5.3 million by 2025. Type 2 diabetes accounts for over 90% of these cases with associated treatment costs of approximately £8.8 billion per year. Early intervention is key to reduce disease burden, with efforts often directed at those with prediabetes: an umbrella term for individuals with impaired fasting glucose, impaired glucose tolerance, or elevated glycated haemoglobin (HbA1c). Adults with prediabetes have an increased risk of developing type 2 diabetes and cardiovascular disease, as well as associated microvascular complications such as retinopathy, neuropathy, and nephropathy. Lifestyle interventions can help delay or prevent the progression of prediabetes to type 2 diabetes, thereby reducing morbidity. Such interventions, however, can be challenging to implement and a lack of long-term adherence can limit their effectiveness. It is therefore important to develop low-cost, novel adjunct therapies to improve glycaemic control 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 diabetic 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 prediabetes.

Details
Condition PreDiabetes, Hyperglycemia
Treatment Placebo, beta-alanine
Clinical Study IdentifierNCT05329610
SponsorNottingham Trent University
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females aged 18 to 75 years
Body Mass Index (BMI) ≥25 to <40 kg/m2
Able to provide informed consent
Evidence of prediabetes (at high-risk of developing T2DM; NICE, 2017). Defined as: HbA1c: ≥6.0 to 6.4% (42 to 47 mmol/mol) or fasting plasma glucose: ≥5.5 to 6.9 mmol/L

Exclusion Criteria

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
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
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