Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000728730
Ethics application status
Approved
Date submitted
1/07/2013
Date registered
2/07/2013
Date last updated
2/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ramadan: A model for studying the effects of restricted time feeding on metabolic parameters and body composition in humans
Scientific title
Ramadan: A model for studying the effects of restricted time feeding on metabolic parameters and body composition in humans
Secondary ID [1] 282771 0
Nil.
Universal Trial Number (UTN)
U1111-1145-2186
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 289521 0
Condition category
Condition code
Oral and Gastrointestinal 289846 289846 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 289847 289847 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects will be studied on six occasions: (i) twice in the week before Ramadan (i.e. while maintaining their normal eating patterns), (ii) twice during the last week of Ramadan (while fasting from dawn to sunset), and (iii) twice 2 weeks after the end of Ramadan (i.e. following return to their normal eating patterns).
Prior to their enrolment in the study, subjects will attend the hospital for a screening visit, where they will complete questionnaires to assess their medical history, and will provide written, informed consent. They will be provided with a food diary in which they will be required to record all of the food that they eat for a period of 3 days (2 weekdays and 1 weekend day) prior to their first study visit. They will also be instructed to record the time at which they eat.
In the week before Ramadan, each subject will attend the hospital on two occasions. Diabetic subjects will be instructed to abstain from taking their medications on the day of the study visits. On the first visit, subjects will attend the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders at 12 pm, following a 5 hour fast from 7 am, where resting energy expenditure and respiratory quotient will be measured by indirect calorimetry for 60 minutes. Anthropometry (body weight, waist circumference) and body composition (by DEXA) will also be determined.
On the second visit, participants with attend the RPAH between 5-6.30 pm, following a 10 hour fast from 7 am. On arrival, subjects will be seated comfortably and an intravenous cannula will be positioned into an antecubital vein of the arm to enable repeated blood sampling. Baseline blood samples will be collected to measure metabolic parameters, including a full blood count, glucose, HBA1C, lipids, liver function tests, insulin, c-peptide, thyroid function and FFAs, and for assessment of appetite regulating hormones (including gut derived appetite regulating hormones such as ghrelin, insulin, GLP-1, pYY and CCK, and leptin). Participants will also be asked to complete a visual analogue scale (VAS) questionnaire to assess perceptions of appetite and gastrointestinal symptoms. Following baseline assessments, participants will ingest a standardised meal (energy, macronutrient composition. Following meal ingestion, blood samples will be collected, and VAS completed, at 15, 30, 45, 60, 90 and 120 minutes.
The participants will not be given any special instruction about their dietary intake during Ramadan.
In the last week of Ramadan and at two weeks after Ramadan each participant will record their food intake for 3-days (2 weekdays and 1 weekend day) using a food diary, and will attend the laboratory on two days when the measurements described above will be repeated.
Intervention code [1] 287440 0
Not applicable
Comparator / control treatment
N/A. This is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289911 0
Gut hormone response to a nutrient meal will be measured by taking serial blood samples. Gut hormones will be measured using a commercially available multiplex assay kit.
Timepoint [1] 289911 0
Baseline (BL) and every 15 minutes for two hours post meal ingestion at two visits, pre and post Ramadan.
Secondary outcome [1] 303535 0
Blood glucose levels will be assessed using a glucometer in serially collected blood samples.
Timepoint [1] 303535 0
BL and every 15 minutes for two hours post meal ingestion at two visits, pre and post Ramadan.
Secondary outcome [2] 303536 0
Plasma insulin will be assessed in serially collected blood samples using a commercial assay.
Timepoint [2] 303536 0
BL and every 15 minutes for two hours post meal ingestion at two visits, pre and post Ramadan.
Secondary outcome [3] 303537 0
Appetite perceptions will be assessed by asking participants to rate how they feel (i.e. hunger, fullness) on a 100 mm visual analogue scale questionnaire.
Timepoint [3] 303537 0
BL and every 15 minutes for two hours post meal ingestion at two visits, pre and post Ramadan.
Secondary outcome [4] 303538 0
HbA1C will be measured in blood samples by pathology laboratory.
Timepoint [4] 303538 0
Baseline measurement pre and post Ramadan
Secondary outcome [5] 303539 0
Body weight and composition by DXA
Timepoint [5] 303539 0
Pre and post Ramadan
Secondary outcome [6] 303540 0
Energy expenditure by indirect calorimetry
Timepoint [6] 303540 0
Pre and post Ramadan
Secondary outcome [7] 303541 0
Thyroid function tests will be measured in blood samples by pathology laboratory.
Timepoint [7] 303541 0
Pre and post Ramadan
Secondary outcome [8] 303542 0
Blood lipids will be measured in blood samples by pathology laboratory.
Timepoint [8] 303542 0
Pre and post Ramadan
Secondary outcome [9] 303543 0
Liver function tests will be measured in blood samples by pathology laboratory.
Timepoint [9] 303543 0
Pre and post Ramadan
Secondary outcome [10] 303544 0
Serum free fatty acids will be measured in blood samples by pathology laboratory.
Timepoint [10] 303544 0
Pre and post Ramadan
Secondary outcome [11] 303545 0
C-peptide levels in the blood will be measured in blood samples by pathology laboratory.
Timepoint [11] 303545 0
Pre and post Ramadan

Eligibility
Key inclusion criteria
Study participants must meet the following inclusion criteria to be eligible to take part in the study.
Diabetic Cohort
(i) Male or post-menopausal female Type 2 diabetic patients aged 18-65 years
(ii) HbA1c less than 8.5%
(iii) Not on insulin or incretin mimetic treatment
(iv) BMI less than 40 kg/m2
(v) Not known to have any haemoglobinopathies
Non-Diabetic cohort
(i) No history of diabetes
(ii) Both males and post-menopausal females are eligible
(iii) HbA1c less than 5.7%
(iv) BMI less than 40 kg/m2
(v) Not known to have any haemoglobinopathies
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age greater than 65 years.
Poorly controlled type 2 diabetes, HbA1C greater than 8.5%
BMI greater than 40 kg/m2

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Sample size was determined based on our past experience of similar protocols, and is designed as a pilot study. Statistical analysis will be by parametric or non-parametric comparisons of means, eg. t-tests or ANOVAs as appropriate. Measures will be corrected for multiple comparisons.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
31/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1193 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 7055 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 287540 0
Hospital
Name [1] 287540 0
Royal Prince Alfred Hospital Diabetes Centre
Country [1] 287540 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
A/Prof. Amanda Salis
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
THE UNIVERSITY OF SYDNEY
G86 Medical Foundation Building K25,
The University of Sydney
NSW, 2006
Country
Australia
Secondary sponsor category [1] 286292 0
None
Name [1] 286292 0
Address [1] 286292 0
Country [1] 286292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289518 0
Research Ethics Committee (RPAH Zone)
Ethics committee address [1] 289518 0
Ethics committee country [1] 289518 0
Australia
Date submitted for ethics approval [1] 289518 0
Approval date [1] 289518 0
25/06/2013
Ethics approval number [1] 289518 0
X13-0207 and HREC/13/RPAH/247

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

Contacts
Principal investigator
Name 41166 0
A/Prof Amanda Salis
Address 41166 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
THE UNIVERSITY OF SYDNEY
G86 Medical Foundation Building K25
The University of Sydney
NSW, 2006
Country 41166 0
Australia
Phone 41166 0
+61 (0) 423 777 801
Fax 41166 0
Email 41166 0
[email protected]
Contact person for public queries
Name 41167 0
Tanya Little
Address 41167 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
THE UNIVERSITY OF SYDNEY
G86 Medical Foundation Building K25
The University of Sydney
NSW, 2006
Country 41167 0
Australia
Phone 41167 0
+61 2 9036 3061
Fax 41167 0
Email 41167 0
[email protected]
Contact person for scientific queries
Name 41168 0
Tanya Little
Address 41168 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
THE UNIVERSITY OF SYDNEY
G86 Medical Foundation Building K25
The University of Sydney
NSW, 2006
Country 41168 0
Australia
Phone 41168 0
+61 2 9036 3061
Fax 41168 0
Email 41168 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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