Taurine and Nitrate Supplementation on Thermoregulatory in T2DM

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorUniversity of Portsmouth

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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,

  • 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.

  • 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.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 3 interventions
Group B: TaurineActive comparator 2 interventions
Group C: Beetroot and TaurineActive comparator 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

Local sweat rate:

The Q-sweat (Qsweat Quantitative Sweat Measurement System, WR Medical Electronics Co., Minnesota, USA) will be used to understand LSR during the heat event. Participants will be instrumented with the ventilated sweat capsule and placed on the upper back (mid scapula) and onto the mid anterior forearm. Additionally, measuring the forearm may provide insight into regional differences and any autonomic dysfunction in sudomotor response. This will be measured continuously throughout the investigation through the software TestWorks (TestWorks software, WR Medical Electronics Co., Maplewood, MN, USA). Live data will be gathered during the trials and subsequent data will be processed into one-minute averages across each trial.

Time frame
through study completion, average 1 week
2

Rectal temperature Trec

Trec will be measured continuously (1s intervals) throughout each trial. This will be measured via a rectal thermistor (PROACT Temperature Probes, Northamptonshire, United Kingdom).

Time frame
through study completion, average 1 week
3

Skin temperature: Tsk

Tsk will be assessed using four skin thermistors (Grant Instruments, Cambridge, UK), at the sites on the right side of the body at the locations, pectoralis major, biceps brachii, mid-thigh and the gastrocnemius. Thermistors will be placed during the instrumentation part at the start of the protocol and will remain on location until the session has concluded. Data will be recorded throughout the whole duration of the experimental protocol. These will be held in place by a Tegaderm™ dressing (Tegaderm™ Dressings, 3M, St. Paul, Minnesota, USA) with additional tape anchoring them to the skin to avoid movement. Minute averages will be recorded for the duration of the protocol and plotted to understand the change in temperature throughout each trial, to provide information on the specific temperatures that have been identified. Mean skin temperature = (0.3\*Tpectorlis) + (0.3\*Tbicep) + (0.2\*Tthigh) + (0.2\*Tcalf) \*expressed as an indication of multiplication.

Time frame
through study completion, average 1 week
4

Mean Body temperature

Mean body temperature will be measured to provide an overall measure of heat gain for the individual through the combination of Trec and Tsk. The weighting of the different measures of temperature is determined by the ambient temperature of the surrounding, as the protocol will be of a hot environment the below equation was chosen over other weightings, which is as below in Equation two (Burton et al., 2025). This will be measured at all time points that Trec and Tsk are taken in conjunction with each other. This will be measured as absolute values in degrees Celsius, for all time points and also be expressed as a delta change from the baseline temperature or between other specific time points chosen, to provide an understanding of the rate of change. Mean body temperature = Tˉsk=0.3(Tchest+Tarm)+0.2(Tthigh+Tcalf)

Time frame
through study completion, average 1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Portsmouth

Lead sponsor

Swansea University

Collaborator

Portsmouth Hospitals NHS Trust

Collaborator

University of Southampton

Collaborator

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