Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001008718
Ethics application status
Approved
Date submitted
5/07/2022
Date registered
19/07/2022
Date last updated
19/07/2022
Date data sharing statement initially provided
19/07/2022
Date results information initially provided
19/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a peanut-rich weight loss diet on risk of diabetes
Scientific title
Comparison of a peanut-rich weight loss diet compared to a conventional weight loss diet over 6 months on serum insulin, plasma glucose and 2 hour glucose after a GTT in overweight adults at increased risk of diabetes
Secondary ID [1] 307501 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 326916 0
diabetes 326917 0
Condition category
Condition code
Metabolic and Endocrine 324110 324110 0 0
Diabetes
Diet and Nutrition 324149 324149 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
weight loss diet containing 35g of peanuts before 2 main meals over 6 months in men and women with a BMI>26 at increased risk over type 2 diabetes. Both the peanut diet and the control diet were calorie controlled (1500-1600 calories) but composition was not specified. Peanuts were provided to the peanut group and equivalent value vouchers to the control group. The Duration of the diet was 6 months. Food records were filled in as well as a daily peanut consumption record
Intervention code [1] 323958 0
Lifestyle
Intervention code [2] 323959 0
Treatment: Other
Intervention code [3] 323960 0
Prevention
Comparator / control treatment
Conventional low fat weight loss diet (1500-1600 calories).. Broad guidelines on calorie control and example menus were provided to the participants. All food was sourced by the participants but vouchers equal in value to the peanuts provided to the peanut group were supplied. The duration of the diet was 6 months. Food records were fillled in at each visit.
Control group
Active

Outcomes
Primary outcome [1] 331918 0
serum insulin from venous blood sample
Timepoint [1] 331918 0
0 and 6 months after starting diet
Primary outcome [2] 331958 0
fasting glucose from venous blood sample
Timepoint [2] 331958 0
baseline and 6 months after starting diet
Primary outcome [3] 331960 0
2 hour glucose after 75g glucose load from venous blood sample
Timepoint [3] 331960 0
baseline and 6 months after starting diet
Secondary outcome [1] 411589 0
weight measured on digital scales in clinic
Timepoint [1] 411589 0
0 and 6 months after starting diet
Secondary outcome [2] 411735 0
Blood pressure measured in clinic using a sphygmomanometer
Timepoint [2] 411735 0
baseline and 6 months after starting diet

Eligibility
Key inclusion criteria
BMI>26
AUSDRISK score>6
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were previous surgery for weight reduction, systolic blood pressure >160mmHg, currently undergoing medical treatment for acute illness, participation in an-other ongoing clinical trial, current weight loss diet and unwillingness to eat peanuts. In-dividuals taking diabetes or obesity medication were not eligible.

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 not concealed as it is a diet trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The mixed-models procedure (PROC MIXED) was used to examine the effect of diet on each outcome. Visit was modeled as a repeated effect to account for the repeated-measures design. Diet was modeled as a fixed effect and the baseline value was included as a covariate. When a main effect of diet, visit or diet by visit was detected, post hoc pairwise comparisons were conducted and the Tukey–Kramer method was used to adjust for multiple comparisons; data from post hoc testing are presented as the pairwise mean difference and 95% CI with the Tukey– Kramer adjusted P value. Sex effects and sex by diet interactions were also evaluated. Statistical significance was set at p< 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
31/05/2021
Date of last data collection
Anticipated
Actual
6/12/2021
Sample size
Target
100
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311779 0
Commercial sector/Industry
Name [1] 311779 0
The Peanut Institute
Country [1] 311779 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
peanut institute
Address
The Peanut Institute
P.O. Box 70157
Albany, Georgia 31708
Country
United States of America
Secondary sponsor category [1] 313249 0
None
Name [1] 313249 0
Address [1] 313249 0
Country [1] 313249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311220 0
University of South Australia Human Research Ethics committee
Ethics committee address [1] 311220 0
https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/
humanethics@unisa.edu.au, researchintegrity@unisa.edu.au
Ethics committee country [1] 311220 0
Australia
Date submitted for ethics approval [1] 311220 0
01/08/2020
Approval date [1] 311220 0
23/10/2020
Ethics approval number [1] 311220 0
Application ID: 203354;

Summary
Brief summary
We aimed to show that a peanut-enriched weight loss diet would improve markers of diabetes compared with a standard low far weight loss diet. We expected given the same degree of energy restriction that both diets would provide a similar weight loss outcome
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120378 0
Prof Peter Clifton
Address 120378 0
University of South Australia
Frome Rd Adelaide
SA 5000
Country 120378 0
Australia
Phone 120378 0
+61403197998
Fax 120378 0
Email 120378 0
peter.clifton@unisa.edu.au
Contact person for public queries
Name 120379 0
Prof Peter Marshall Clifton
Address 120379 0
University of South Australia
Frome Rd Adelaide
SA 5000
Country 120379 0
Australia
Phone 120379 0
+61 403197998
Fax 120379 0
Email 120379 0
peter.clifton@unisa.edu.au
Contact person for scientific queries
Name 120380 0
Prof Peter Clifton
Address 120380 0
University of South Australia
Frome Rd Adelaide
SA 5000
Country 120380 0
Australia
Phone 120380 0
+61403197998
Fax 120380 0
Email 120380 0
peter.clifton@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
weight
biochemistry
blood pressure
When will data be available (start and end dates)?
5/7/2022- no end date
Available to whom?
all
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
email PI peter.clifton@unisa.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16542Clinical study report    publication-when available



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.