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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02030249




Registration number
NCT02030249
Ethics application status
Date submitted
12/12/2013
Date registered
8/01/2014
Date last updated
30/04/2021

Titles & IDs
Public title
Sub-Study of the PREVIEW Study Australia
Scientific title
Sub-Study of the PREVIEW Study Australia: Effects of Weight Loss on Appetite, Bone Mass and Muscle Strength
Secondary ID [1] 0 0
KBBE-CALL- 6-Nr. 312057
Secondary ID [2] 0 0
2013/535 - SUB-STUDY
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 0 0
Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Low calorie diet administered from 0 to 2 months
BEHAVIORAL - High Protein / Low Glycaemic Index
BEHAVIORAL - Moderate Protein / High Glycaemic Index

Experimental: High Protein / Low Glycaemic Index - A 10-month weight maintenance diet, administered from the 2-month to the 12-month time point, where protein intake is 25% of energy intake, carbohydrate intake is 45% of energy intake, dietary glycaemic index is \< 55. Please see parent study for further Arm details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview\&rank=1

Active comparator: Moderate Protein / High Glycaemic Index - A 10-month weight maintenance diet, administered from the 2-month to the 12-month time point, where protein intake is 15% of energy intake, carbohydrate intake is 55% of energy intake, dietary glycaemic index is \> 65. Please see parent study for further Arm details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview\&rank=1


BEHAVIORAL: Low calorie diet administered from 0 to 2 months
The 2-month low calorie diet is administered from the 0 months to the 2 months time point. It is designed to elicit a weight loss of 8% of initial body weight. Please see parent study for further intervention details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview\&rank=1

BEHAVIORAL: High Protein / Low Glycaemic Index
Please see description of the Arm by the same name.

BEHAVIORAL: Moderate Protein / High Glycaemic Index
Please see description of the Arm by the same name.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting appetite
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Bone mass
Timepoint [2] 0 0
2 months
Secondary outcome [1] 0 0
Fasting appetite
Timepoint [1] 0 0
0 months
Secondary outcome [2] 0 0
Fasting appetite
Timepoint [2] 0 0
2 months
Secondary outcome [3] 0 0
Fasting appetite
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Fasting appetite
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Fasting appetite
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Fasting plasma concentrations of gut-derived appetite-regulating hormones
Timepoint [6] 0 0
0 months
Secondary outcome [7] 0 0
Fasting plasma concentrations of gut-derived appetite-regulating hormones
Timepoint [7] 0 0
2 months
Secondary outcome [8] 0 0
Fasting plasma concentrations of gut-derived appetite-regulating hormones
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Fasting plasma concentrations of gut-derived appetite-regulating hormones
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Fasting plasma concentrations of gut-derived appetite-regulating hormones
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Fasting plasma concentrations of gut-derived appetite-regulating hormones
Timepoint [11] 0 0
36 months
Secondary outcome [12] 0 0
Bone mass
Timepoint [12] 0 0
0 months
Secondary outcome [13] 0 0
Bone mass
Timepoint [13] 0 0
2 months
Secondary outcome [14] 0 0
Bone mass
Timepoint [14] 0 0
6 months
Secondary outcome [15] 0 0
Bone mass
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Bone mass
Timepoint [16] 0 0
36 months
Secondary outcome [17] 0 0
Bone turnover
Timepoint [17] 0 0
0 months
Secondary outcome [18] 0 0
Bone turnover
Timepoint [18] 0 0
2 months
Secondary outcome [19] 0 0
Bone turnover
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Bone turnover
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Bone turnover
Timepoint [21] 0 0
24 months
Secondary outcome [22] 0 0
Bone turnover
Timepoint [22] 0 0
36 months
Secondary outcome [23] 0 0
Modulators of bone turnover
Timepoint [23] 0 0
0 months
Secondary outcome [24] 0 0
Modulators of bone turnover
Timepoint [24] 0 0
2 months
Secondary outcome [25] 0 0
Modulators of bone turnover
Timepoint [25] 0 0
6 months
Secondary outcome [26] 0 0
Modulators of bone turnover
Timepoint [26] 0 0
12 months
Secondary outcome [27] 0 0
Modulators of bone turnover
Timepoint [27] 0 0
24 months
Secondary outcome [28] 0 0
Modulators of bone turnover
Timepoint [28] 0 0
36 months
Secondary outcome [29] 0 0
Muscle (handgrip) strength
Timepoint [29] 0 0
0 months
Secondary outcome [30] 0 0
Muscle (handgrip) strength
Timepoint [30] 0 0
2 months
Secondary outcome [31] 0 0
Muscle (handgrip) strength
Timepoint [31] 0 0
6 months
Secondary outcome [32] 0 0
Muscle (handgrip) strength
Timepoint [32] 0 0
12 months
Secondary outcome [33] 0 0
Muscle (handgrip) strength
Timepoint [33] 0 0
24 months
Secondary outcome [34] 0 0
Muscle (handgrip) strength
Timepoint [34] 0 0
36 months

Eligibility
Key inclusion criteria
* Age 25 - 45 years and 55 - 70 years
* Overweight or obesity status BMI>25 kg/m2
* Pre-diabetes. The criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 - 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an inclusion criteria in the screening.
* Informed consent required
* Ethnic group - No restrictions
* Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
* Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol
* Other - Able to participate at CID's during normal working hours.
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Based on interview and/or questionnaire, individuals with the following problems will be excluded:

* Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder).
* Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
* Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol.
* Laboratory screening: If all of the above criteria are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation.
* ONLY IF the glucose tolerance test meets the entry criteria for the study, the remaining samples are sent to the local laboratory for a safety check, with the following exclusion criteria: Hemoglobin concentration below local laboratory reference values (i.e. anemia); Creatinine >1.5 times Upper Limit of Normal (local laboratory reference values); Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values); Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment.
* Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age.
* After LCD phase (in adults): Failure to reach at least 8% weight reduction during the LCD phase. This leads to exclusion from the intervention.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
292
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of Sydney - Camperdown
Recruitment hospital [2] 0 0
Garvan Institute of Medical Research - Darlinghurst, Sydney
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [3] 0 0
2031 - Randwick, Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Salis (nee Sainsbury), PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02030249