β-alanine Supplementation in Adults With Overweight/Obesity

NCT05329610 | Completed

• 1 other identifier: 676
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Prediabetes; Hyperglycemia; Overweight or Obesity

Keywords

Prediabetes; Hyperglycemia; Carnosine; Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Adherence to the intervention

  Probability that a randomised participant receives the assigned intervention.

  3-months (endpoint)

Secondary Outcomes (4)

• Recruitment

  Baseline

• Attrition rate

  3-months (endpoint)

• Side effects

  Baseline and 3-months (endpoint)

• Blinding to the intervention

  3-months (endpoint)

Other Outcomes (55)

• Body weight (kg)

  Baseline and 3-months (endpoint)

• BMI (kg/m2)

  Baseline and 3-months (endpoint)

• Waist circumference (cm)

  Baseline and 3-months (endpoint)

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Beta-alanine DIETARY_SUPPLEMENT

Slow-release beta-alanine.

Beta-alanine

Placebo DIETARY_SUPPLEMENT

Taste and appearance-matched placebo (tapioca starch).

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18 to 75 years
• Body Mass Index (BMI) ≥25 to \<40 kg/m2
• Able to provide informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nottingham Trent University: lead
• Aston University: collaborator

Study Sites (2)

Nottingham Trent University

Nottingham, Nottinghamshire, NG11 8NS, United Kingdom

Location

Aston University

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Prediabetic State; Hyperglycemia; Overweight; Obesity

Interventions

beta-Alanine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Craig Sale, PhD

  Nottingham Trent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All participants, data collectors, and outcome assessors will be blind to the group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher

Model Details: A double-blinded, randomised, placebo-controlled, parallel group, feasibility trial. The allocation ratio of treatment to placebo will be 1:1.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: April 15, 2022
• Study Start: April 5, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)