Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000265279
Ethics application status
Approved
Date submitted
4/03/2009
Date registered
14/05/2009
Date last updated
14/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised parallel dietary intervention to compare the effects of daily consumption of nuts, potato crisps and chocolate for 12 weeks on body weight in healthy adults.
Scientific title
A randomised parallel dietary intervention to compare the effects of daily consumption of nuts, potato crisps and chocolate for 12 weeks on body weight in healthy subjects.
Secondary ID [1] 821 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participants will be healthy.
Health condition being prevented: Obesity 4421 0
Condition category
Condition code
Diet and Nutrition 4685 4685 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, parallel, intervention study with four arms: nuts, potato crisps, chocolate, control (no additional food). This study will be carried out to assess the effects of consuming energy-dense foods everyday for 12 weeks on energy balance, body weight, cardiovascular risk factors and sensory response. The foods will include 42g (1100KJ) of hazelnuts, 50g (1100KJ) of potato crisps or 50g (1100KJ) of chocolate. For the first two weeks of the study, the participants will consume their normal diet (Baseline). After this two-week period, they will be randomly allocated to one of the four groups for 12 weeks. The study lasts 14 weeks in total.
Intervention code [1] 4163 0
Lifestyle
Comparator / control treatment
Control group – No treatment. The control group will receive no additional food during the intervention.
Control group
Active

Outcomes
Primary outcome [1] 5552 0
Body weight. This will be measured using bioelectrical impedance analysis.
Timepoint [1] 5552 0
At baseline and at 6 and 12 weeks after intervention commencement
Secondary outcome [1] 9352 0
Body composition. This will be measured by dual energy x-ray absorptiometry.
Timepoint [1] 9352 0
At baseline and at 12 weeks after intervention commencement
Secondary outcome [2] 9353 0
Plasma lipids and lipoproteins. Plasma total cholesterol, high density lipoprotein (HDL) cholesterol and triacylglycerol concentrations will be measured by enzymatic methods using kits and calibrators supplied by Roche Diagnostics (Mannheim, Germany) on a Cobas Mira Plus Analyser. High density lipoprotein (HDL) cholesterol will be measured in the supernatant following precipitation of apoprotein B containing lipoproteins with phosphotungstate-magnesium chloride solution (Assmann et al., 1983). Plasma low density lipoprotein (LDL) cholesterol concentration will be calculated using the Friedewald formula (Friedewald et al., 1972).
Timepoint [2] 9353 0
At baseline and at 6 and 12 weeks after intervention commencement
Secondary outcome [3] 9354 0
Sensory specific satiety. Participants will be asked to attend a tasting session and complete a series of ballots. Firstly, they will be asked to rate their appetite indices rating (hunger, thirst, desire to eat, how much they think they could eat, fullness and preoccupation with thoughts of food) on a 100mm visual analogue scale. They will then taste six food samples (potato crisps, pretzels, hazelnuts, marshmallow, chocolate, shortbread biscuit) and rate their overall liking of each food (pre-treatment set). Following this they will be provided with either nuts, chocolate or potato crisps (depending on randomisation) that they can consume as much of the snacks as they want. Participants will repeat appetite indices rating. Finally participants will be asked to re-taste and re-rate their overall liking of the six food samples (post-treatment set). Sensory specific satiety scores for each snack are created by subtracting the mean change (mean difference between before treatment consumption and after) for overall liking for the rated sample set (not including the treatment) from the change (difference between before treatment consumption and after) for overall liking of the treatment in the rated sample set.
Timepoint [3] 9354 0
At baseline and at 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
The inclusion criteria are healthy males and females aged between 18 and 65 years
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are
- People with a Body Mass Index (BMI) equal to or greater than 30 [weight(kg) / height (m2)]
- People who have asthma
- People who have food allergies or food aversions to nuts
- People with a chronic disease, e.g. cancer, heart disease, or diabetes

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)
Allocation concealment will be used. This will be achieved through allocation being performed by the statistician who will have no involvement in the enrollment process and is located in another building. Once participants have been accepted into the study, sufficient details for allocation (study number, age, sex, BMI) will be sent to the statistician who will return group allocation codes once blocks are complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated using random sequences of the four groups generated using SAS 9.1.3. Due to the strong possibility of age, sex, and BMI effects, groups will be balanced using 8 strata constructed using sex (M/F), age (18-40, 41-65), and BMI (-24.9, 25-29.9) categories. Allocation will be conducted by the "off-site" statistician within each strata. Incomplete blocks remaining at the conclusion of enrolment will be allocated first using strata based on sex and BMI and then BMI, and finally without stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 1646 0
New Zealand
State/province [1] 1646 0
Otago

Funding & Sponsors
Funding source category [1] 4609 0
University
Name [1] 4609 0
University of Otago Standard Research Grant
Country [1] 4609 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 4157 0
None
Name [1] 4157 0
Address [1] 4157 0
Country [1] 4157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6655 0
University of Otago Human Ethics Committee
Ethics committee address [1] 6655 0
University of Otago Human Ethics Committee, PO Box 56, Dunedin 9054
Ethics committee country [1] 6655 0
New Zealand
Date submitted for ethics approval [1] 6655 0
09/02/2009
Approval date [1] 6655 0
03/03/2009
Ethics approval number [1] 6655 0
Reference Number 09/017

Summary
Brief summary
Public health recommendations include regular consumption of nuts. It is important to determine whether nut consumption on a daily basis results in weight gain which may negate the positive health benefits of regular nut consumption. Some previous research suggests that nuts may possess unique characteristics that prevent weight gain, even though they are high in fat and calories. No studies to date have compared regular nut consumption with regular consumption of other energy dense foods.

If there is something unique about nuts, which prevents weight gain, then there is the potential to include nuts in the diets of those who in particular struggle to maintain a healthy body weight, e.g. ex-smokers, yo-yo dieters, individuals with the metabolic syndrome.

Therefore, the purpose of this study is to assess energy balance, body weight, cardiovascular risk factors and sensory response to the daily consumption of nuts for twelve weeks compared with the consumption of other energy-dense foods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29353 0
Address 29353 0
Country 29353 0
Phone 29353 0
Fax 29353 0
Email 29353 0
Contact person for public queries
Name 12600 0
Dr Rachel Brown
Address 12600 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 12600 0
New Zealand
Phone 12600 0
+64 3 4795839
Fax 12600 0
+64 3 4797958
Email 12600 0
rachel.brown@otago.ac.nz
Contact person for scientific queries
Name 3528 0
Dr Rachel Brown
Address 3528 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 3528 0
New Zealand
Phone 3528 0
+64 3 4795839
Fax 3528 0
+64 3 4797958
Email 3528 0
rachel.brown@otago.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

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