Taurine and Nitrate Supplementation on Thermoregulatory in T2DM

NCT07656051 | Not Yet Recruiting

• 2 other identifiers: 370139UP/226698
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anthropogenic warming is increasing the frequency and intensity of extreme heat events. Elevated temperatures raise the risk of mortality and hospital admissions, particularly among people with chronic illnesses such as type 2 diabetes mellitus (T2DM). Globally, around 530 million people live with T2DM , and in the United Kingdom nearly six million are affected, creating a substantial population vulnerable to heat related illness. People with T2DM are at heightened risk of cardiovascular disease, which can impair cardiac output, a key component of thermoregulation, as it supports increased skin blood flow for heat dissipation. T2DM also attenuates eccrine sweat gland function, peripheral vasodilation, reducing evaporative cooling capacity. These physiological constraints highlight the need for effective strategies to improve heat tolerance in this group. Recent evidence shows that exogenous taurine supplementation can enhance sweating in healthy individuals, potentially improving heat loss. This study will examine whether acute taurine supplementation, alone or combined with beetroot, can limit rises in core temperature in people with T2DM during an acute extreme heat exposure.

Conditions

Type 2 Diabetes

Keywords

climate; taurine; nitrate; heat

Outcome Measures

Primary Outcomes (1)

• Whole body sweat rate

  WBSR will be measured by taking a nude body mass (kg). Participants will be shown to a private changing facility in which the scales (Industrial Electronic Weight Indicator, Model 10, Ohaus Corporation, Parsippany, NJ, US) are located, with the screen for the value reading located outside to ensure privacy of the participant. The pre-mass measure will occur during every experimental visit, before the instrumentation section of the visit. Towel dried nude body mass will then be recorded once de-instrumentation has occurred. The equation below will be used to calculate WBSR. WBSR (L/h) equation: (Pre body mass (kg) - Post body mass (kg)) + Fluid intake (L) - Urine output (L) Duration of test (hrs)

  Baseline and immediately post heating (3 hour post-baseline)

Secondary Outcomes (18)

• Local sweat rate:

  through study completion, average 1 week

• Rectal temperature Trec

  through study completion, average 1 week

• Skin temperature: Tsk

  through study completion, average 1 week

• Mean Body temperature

  through study completion, average 1 week

• Cardiac output

  through study completion, average 1 week

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo will include the 20g nitrate placebo from above and 5g of maltodextrin (100% Maltodextrin Carbs, myprotein, UK) which will also be added to 305 mL water.

Dietary Supplement: taurine; Dietary Supplement: Beetroot and taurine; Dietary Supplement: Placebo

Taurine

ACTIVE COMPARATOR

The taurine supplement will be administered as a 5g (100% taurine powder, myprotein, UK) dose. To taste match the beetroot arm we will use a nitrate depleted powder. The placebo contained 1.6% nitrate (180 mg nitrate; Bio-gen Extracts Private Limited, Karnataka, India). The servings contained 13.33g of nitrate depleted beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic \& citric acid). The beetroot powders were prepared by manipulating the processing control parameters (extraction time and temperature) during extract preparation to ensure precise nitrate concentration across the different conditions, particularly for the placebo. Specifically, raw beetroot was extracted with water for 1 h at \>90°C with the residue obtained from the first extraction processed to obtain the low nitrate grade material. The NO3- content of beetroot powders were determined by treating the samples with a salicylic acid-sulphuric acid mixture

Dietary Supplement: taurine; Dietary Supplement: Placebo

Beetroot and Taurine

ACTIVE COMPARATOR

20g of formulated beetroot power containing \~6% nitrate (800mg NO3-; TruBeet; Bio-gen Extracts Private Limited). The servings contained 13.33g of the formulated beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic \& citric acid) and 5g (100% taurine powder, myprotein, UK) of taurine will also be added to 305mL water prior to ingestion.

Dietary Supplement: Beetroot and taurine

Interventions

taurine DIETARY_SUPPLEMENT

The taurine supplement will be administered as a 5g (100% taurine powder, myprotein, UK) dose. To taste match the beetroot arm we will use a nitrate depleted powder. The placebo contained 1.6% nitrate (180 mg nitrate; Bio-gen Extracts Private Limited, Karnataka, India). The servings contained 13.33g of nitrate depleted beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic \& citric acid). The beetroot powders were prepared by manipulating the processing control parameters (extraction time and temperature) during extract preparation to ensure precise nitrate concentration across the different conditions, particularly for the placebo. Specifically, raw beetroot was extracted with water for 1 h at \>90°C with the residue obtained from the first extraction processed to obtain the low nitrate grade material. The NO3- content of beetroot powders were determined by treating the samples with a salicylic acid-sulphuric acid mixture,

Placebo; Taurine

Beetroot and taurine DIETARY_SUPPLEMENT

20g of formulated beetroot power containing \~6% nitrate (800mg NO3-; TruBeet; Bio-gen Extracts Private Limited). The servings contained 13.33g of the formulated beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic \& citric acid) and 5g (100% taurine powder, myprotein, UK) of taurine will also be added to 305mL water prior to ingestion.

Beetroot and Taurine; Placebo

Placebo DIETARY_SUPPLEMENT

Placebo will include the 20g nitrate placebo from above and 5g of maltodextrin (100% Maltodextrin Carbs, myprotein, UK) which will also be added to 305 mL water.

Placebo; Taurine

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (post-menopausal) aged 35 years or above.
• Diagnosed with T2DM as defined by the WHO (HbA1c ≥48 mmol/mol).
• Willing and able to give informed consent for participation in the study.
• Able to understand and fully cooperate with the study protocol.

You may not qualify if:

• Severe peripheral neuropathy (to the point to which they cannot sense temperature)
• Uncontrolled hypertension (≥180 systolic / 100 diastolic)
• Significant renal impairment (eGFR \< 30)
• Diagnosed anhidrosis
• Taking any medication which may interfere with data interpretation or safety
• Who have had a myocardial infarction or cerebrovascular event
• Any cardiac abnormalities which restrict hard exercise
• Any allergies to the ingredients used in the supplements
• BMI \>40
• Current smokers or who have stopped within 3 months
• Unable to understand and/or fully cooperate with the study protocol
• Any serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
• Open wounds
• Skin ulcerations (that would interfere with data collection and interpretation or safety)
• Eczema (that would interfere with data collection and interpretation or safety)

Sponsors & Collaborators

• University of Portsmouth: lead
• Swansea University: collaborator
• Portsmouth Hospitals NHS Trust: collaborator
• University of Southampton: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Taurine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Daniel Piccolo, PhD

CONTACT

+44; daniel.piccolo@port.ac.uk

Ant I Shepherd, PhD

CONTACT

+44239284; ant.shepherd@port.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ant Shepherd (PhD) Associate Professor in Clinical Exercise Physiology

Model Details: This investigation will employ a double blind, placebo-controlled, randomised, crossover design that examines exogenous taurine and taurine combined with beetroot, on thermoregulation during a simulated hot weather event compared to a placebo. Testing

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share