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Trial registered on ANZCTR

Registration number

ACTRN12616001466437

Ethics application status

Approved

Date submitted

13/10/2016

Date registered

20/10/2016

Date last updated

3/11/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Zinc metabolism during exercise and recovery

Scientific title

Zinc metabolism during exercise and recovery in healthy adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

nutrition

zinc metabolism

exercise

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will complete both the exercise and resting session. The order of the two sessions will be randomised. The washout period will be between 3 to 5 weeks.

The exercise intervention session will be a continuous progressive protocol to maximal exercise capacity on a cycle ergometer; the typical duration of the exercise session will be 8-12 minutes depending on individual physical fitness. Initially, participants will complete a 3 min warm up period with no resistance. The exercise session starts at a resistance of 100 W (or 75 W for smaller individuals); the resistance will increase by 50 W every 2.5 min until heart rate reach 160 bpm, then the resistance will increase by 25 W every 2.5 min until maximal exercise capacity. Measures, such as blood, will be taken during the exercise and recovery (up to 2 hours after exercise).

Intervention code [1]

Lifestyle

Comparator / control treatment

In the resting session, the participant will remain sedentary for 2 hours and 10 minutes. The participant will remain seated in a chair for the entire duration of the session, with the exception of bathroom breaks.

Control group

Active

Outcomes

Primary outcome [1]

Serum zinc, unadjusted
Serum zinc, adjusted for haematocrit

Timepoint [1]

Before, immediately after the exercise session, 30 minutes following exercise cessation, 1 hour following exercise cessation and 2 hours following exercise cessation.

For the resting group, 0, 10 min, 40 min, 1h 10 min, 2 h 10 min.

Secondary outcome [1]

Gene expression of zinc transporter (ZIP7)

Gene expression will be measured by Taqman quantitative PCR from blood samples.

Timepoint [1]

Secondary outcome [2]

Urinary zinc excretion

Timepoint [2]

24 h urinary zinc excretion, continuous collection over 24 hours following commencement of the exercise or resting session (exercise group compared to resting)

Secondary outcome [3]

Red blood cell zinc

Timepoint [3]

Secondary outcome [4]

Sex hormones (progesterone and oestrogen) in serum assay

Timepoint [4]

Baseline for females

Secondary outcome [5]

Inflammatory biomarkers (CRP or AGP) in serum assay

Timepoint [5]

Baseline

Secondary outcome [6]

Exercise outcomes (VO2max by expired air gas analysis, rate of perceived exertion by Borg RPE scale, heart rate by chest heart rate sensor)

Timepoint [6]

Exercise outcomes: before exercise, every 3 minutes during exercise, and immediately upon completion of exercise

Resting outcomes, during first 10 minutes of session

Secondary outcome [7]

Gene expression of zinc transporter (ZnT1). Gene expression will be measured by Taqman quantitative PCR from blood samples.

Timepoint [7]

Secondary outcome [8]

Gene expression of metallothioniein (MT-2A)

Gene expression will be measured by Taqman quantitative PCR from blood samples.

Timepoint [8]

Secondary outcome [9]

Neopterins in plasma and urine.

Timepoint [9]

Plasma: Before, immediately after the exercise session, 30 minutes following exercise cessation, 1 hour following exercise cessation and 2 hours following exercise cessation. For the resting group, 0, 10 min, 40 min, 1h 10 min, 2 h 10 min.

Urine: 24h urine collection on resting and exercise day

Eligibility

Key inclusion criteria

Healthy men (n = 30) and women (n = 30), aged 18-30, will be recruited for the study.

Minimum age

18 Years

Maximum age

30 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Haemoglobin will be measured to exclude volunteers with anaemia. Exclusion criteria include: anaemia, habitual smokers, women who may be pregnant or breastfeeding, women who have amenorrhea or oligomenorrhea, those with a diagnosis of major illness, the use of prescription medication including contraceptive agents and medical contraindication to maximal exercise testing.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

25/01/2017

Actual

27/01/2017

Date of last participant enrolment

Anticipated

Actual

1/08/2017

Date of last data collection

Anticipated

Actual

8/09/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Department of Human Nutrition
PO Box 56 Dunedin 9054
New Zealand

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

Department of Human Nutrition
PO Box 56 Dunedin 9054
New Zealand

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

PO Box 56,
Dunedin 9054,
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/10/2016

Approval date [1]

17/01/2017

Ethics approval number [1]

Summary

Brief summary

In our recent meta-analyses, exercise has been shown to induce changes in serum zinc levels. However, the quantified results are confounded by multiple study limitations, for example failure to adjust for exercise-induced changes in blood volume. 
Further, in a previous trial, we observed a significant relationship between habitual physical activity level and zinc transporter gene expression. This suggests that cellular zinc homeostasis may be affected by exercise level, possibly due to exercise adaptations. Therefore, the principal study question is: What is the effect of a maximal cycling exercise bout on markers of zinc homeostasis in healthy men and women? 

Healthy men (n = 60) and women (n = 60), aged 18-30, will be recruited. Recruited participants will be randomised into an exercise session (n = 30 men, 30 women) or a resting session (n = 30 men, 30 women). Pre-screening questionnaire and a measurement of hemoglobin will be used to determine eligibility for participation. 
Height, weight, body composition (by bioelectrical impedance analysis) and habitual physical activity level will be collected. Dietary intake will be evaluated with a 3-day food record. 24-h urine collection will be taken on the exercise/resting day to measure urinary zinc excretion. 
The exercise session will involve a continuous progressive protocol to maximal exercise capacity on a stationary bicycle. Oxygen consumption levels will be measured during the test to obtain level of maximal oxygen consumption (VO2max). Heart rate and rate of perceived exertion will be measured during the test. Blood samples will be collected before exercise, immediately after exercise and at 3 time points during exercise recovery. In the resting session, participants will be sedentary for the blood collection time course. Blood samples will be measured for zinc outcome, gene expressions, haematocrit, sex hormones, inflammatory markers.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Anna Chu

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 3 479 7959

Fax

[email protected]

Contact person for public queries

Name

Anna Chu

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 3 479 7959

Fax

[email protected]

Contact person for scientific queries

Name

Anna Chu

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 3 479 7959

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Simultaneous analysis of neopterin, kynurenine and tryptophan by amine-HPLC shows minor oxidative stress from short-term exhaustion exercise.	2019	https://dx.doi.org/10.1515/pteridines-2019-0003

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically