ANZCTR - Registration

Please note that the copy function is not enabled for this field.
If you wish to modify existing outcomes, please copy and paste the current outcome text into the Update field.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

Please note that the ANZCTR website will be unavailable from 1pm until 2:30pm (AEDT) on Thursday 28th November for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000432213

Ethics application status

Approved

Date submitted

26/02/2018

Date registered

26/03/2018

Date last updated

26/03/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

The gut microbiome: a new pathway to obesity prevention and metabolic health

Scientific title

The gut microbiome: a new pathway to obesity prevention and metabolic health

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1184-0829

Trial acronym

PROMIsE (PRedictors linking Obesity and the MIcrobiomE) Study

Linked study record

Health condition

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

Obesity

Metabolic Health

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

We will conduct a cross sectional study in 136 Pacific women (known high risk of obesity, 68% obesity) and 136 NZ European women (known moderate risk of obesity, 28% obesity). Women will be selected such that half in each group will have a normal body fat profile (BMI=18.5 -24.9kg/m2) and half an obese body fat profile (BMI>=30 kg/m2). We will characterise the gut microbiome in all groups and test whether taste perception, diet, sleep and physical activity are key pathways that modify the gut microbiome and its impact on obesity.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Dietary intake and eating behaviour as assessed by 5-day estimated food record, Food Frequency Questionnaire (FFQ), Dietary Diversity Questionnaire (DDQ), Three-Factor Eating Questionnaire (TFEQ) and Eating Attitudes Test (EAT-26).

Timepoint [1]

Cross-sectional study - one-time measures

Primary outcome [2]

Body composition and body fat profile as assessed by International Society for the Advancement of Kinanthropometry (ISAK) protocol, Bioelectrical Impedance Analysis (BIA), Dual-energy X-ray Absorptiometry (DXA) and Sagittal Abdominal Diameter (SAD).

Timepoint [2]

Cross-sectional study - one-time measures

Primary outcome [3]

Gut microbiome complexity and functionality as assessed by shotgun-sequencing.

Timepoint [3]

Cross-sectional study - one-time measures

Secondary outcome [1]

Intensity and hedonic liking of taste perception (sweet, bitter, fat) as measured by general labelled magnitude scales (gLMS).

Timepoint [1]

Cross-sectional study - one-time measures

Secondary outcome [2]

Sleep as assessed by wrist worn AW2 actiwatch actigraph, 7-day sleep diary, Pittsburgh Sleep Quality Index (PSQI), Munich ChronoType Questionnaire (MCTQ) and Berlin Questionnaire.

Timepoint [2]

Cross-sectional study - one-time measures

Secondary outcome [3]

Physical activity as assessed by w-GT3X triaxial accelerometer, 7-day physical activity diary and Recent Physical Activity Questionnaire (RPAQ).

Timepoint [3]

Cross-sectional study - one time measures

Secondary outcome [4]

Blood metabolic biomarkers (plasma glucose, insulin, HbA1c, lipids), inflammation markers (hs-CRP, IL-6, TNFa) and endocrine regulators (GLP-1, ghrelin, leptin) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays.

Timepoint [4]

Cross-sectional study - one time measures

Eligibility

Key inclusion criteria

1. Provision of written informed consent
2. Willingness to comply with study requirements
3. Female 18-45 years of age, of NZ European or Pacific ethnicity with BMI between 18.5 and 24.9kg/m2 or of BMI greater than or equal to 30kg/m2
4. Generally healthy, no chronic health conditions

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Had bariatric surgery
2 Taking medications affecting the immune system or for any chronic disease
3. Pregnant or breastfeeding an infant less than 6 months of age
4. Chronic illnesses (eg. Diabetes Mellitus, CVD, etc)
5. Allergic to milk
6 Severe dietary restrictions or avoidances
7 Unable to comply with study protocol requirements

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Both

Statistical methods / analysis

We have based our sample size calculations on metagenome-based measures of gene richness (gene counts) of faecal microbial communities which categorise individuals into clusters of high or low gene count. Individuals in the low gene count cluster may be at increased risk of progressing to obesity-associated co-morbidities. All power calculations are based on analyses for each ethnic group separately, as differences in associations between ethnic groups may exist.

Descriptive statistical methods will be used to summarise gut microbiome complexity and functionality, dietary intake and behaviour, sweet and fat taste perception, sleep, physical activity and blood biomarkers. We will first analyse the differential gut microbiome complexity and gene richness between obese body fat profile women and normal body fat profile women stratified by ethnicity using linear regression analyses. We will also assess associations between gut microbiome complexity and functionality and biological and behavioural factors described above. In addition to analysing the gut microbiome complexity and gene richness as a continuous variable, we will also stratify participants into groups with reduced versus high gut microbiome complexity and gene richness, based on the observed differences between groups using cut points employed in previous studies. For this, we will use logistic regression analyses. We will conduct multiple regression analyses to assess the independent effects of the biological and behavioural factors described above and perform stratified analyses to assess effect modification (or interactions). All analyses will initially be stratified by ethnicity. If no differences in associations between ethnic groups are observed, we will combine the groups for analyses. All analyses will be adjusted for potential confounders (e.g. socio-economic position, age).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/07/2016

Date of last participant enrolment

Anticipated

Actual

29/08/2017

Date of last data collection

Anticipated

Actual

18/09/2017

Sample size

Target

272

Accrual to date

Final

278

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland area

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

50 Grafton Road, Grafton, Auckland 1010

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Professor Bernhard Breier (Chair in Human Nutrition)

Address

Private Bag 102904 (Massey University)
North Shore
Auckland 0745

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Rozanne Kruger (Associate Professor in Dietetics and Human Nutrition)

Address [1]

Private Bag 102904 (Massey University)
North Shore
Auckland 0745

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees (Southern Committee)

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

21/03/2016

Approval date [1]

30/03/2016

Ethics approval number [1]

16/STH/32

Summary

Brief summary

The prevalence of obesity has increased substantially over recent decades and interventions to halt the epidemic have been unsuccessful. Although the causes of obesity are complex, key drivers include the overconsumption of highly palatable energy-dense and nutrient-poor foods. These dietary changes have had a profound impact on our gut microbiome, which comprises the bacterial community of the bowel. Exciting new evidence suggests that microbial complexity and functionality in the gut may play a crucial role in obesity. In the proposed study we will characterise the gut microbiome in two populations with markedly different metabolic disease risk (Pacific and European women) and different body fat profiles (normal and obese). We will test whether taste perception, diet, sleep and physical activity are key pathways that modify the gut microbiome and its impact on obesity. This new knowledge will help us understand obesity and how best to prevent it.?

Trial website

www.massey.ac.nz/promise

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Bernhard Breier

Address

Private Bag 102904 (Massey University)
North Shore
Auckland 0745

Country

New Zealand

Phone

+64 9 2136652

Fax

Email

b.breier@massey.ac.nz

Contact person for public queries

Name

Bernhard Breier

Address

Private Bag 102904 (Massey University)
North Shore
Auckland 0745

Country

New Zealand

Phone

+64 9 2136652

Fax

Email

b.breier@massey.ac.nz

Contact person for scientific queries

Name

Bernhard Breier

Address

Private Bag 102904 (Massey University)
North Shore
Auckland 0745

Country

New Zealand

Phone

+64 9 2136652

Fax

Email

b.breier@massey.ac.nz

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	Objectively Measured Physical Activity Is Associated With Body Composition and Metabolic Profiles of Pacific and New Zealand European Women With Different Metabolic Disease Risks.	2021	https://dx.doi.org/10.3389/fphys.2021.684782
Embase	The fecal microbiotas of women of Pacific and New Zealand European ethnicities are characterized by distinctive enterotypes that reflect dietary intakes and fecal water content.	2023	https://dx.doi.org/10.1080/19490976.2023.2178801

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