Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001099415
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
15/08/2016
Date last updated
15/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Two Different Supplemental Oils on Keto-Adaptation and Symptoms of Carbohydrate Withdrawal
Scientific title
The effect of medium chain triglycerides on time to nutritional ketosis and symptoms of keto-induction in healthy adults
Secondary ID [1] 289881 0
None
Universal Trial Number (UTN)
U1111-1186-1232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ketogenesis 299822 0
Obesity 299823 0
Diabetes 299824 0
Metabolic Syndrome 299825 0
Condition category
Condition code
Diet and Nutrition 299746 299746 0 0
Obesity
Metabolic and Endocrine 299775 299775 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled, double-blinded intervention. Comparing the application of supplemental Medium chain triglycerides in the context of a very low carbohydrate, ketogenic diet (VLCKD). A commerical MCT oil (Amtrade Industries NZ) consisting of <1% C:6 (caproic), 50-65% C:8 (caprylic), 34-45% C:10 (capric) acids with less than 3% in other (C:12-C:14) fats, was provided to participants at a dose of 30g, three times per day (total 90g per day, of which approximately 45-58.5g was caprylic acid (C:8) and 30.6-40.5g was capric acid (C:10), for a duration of twenty days. Supplemental oils self-administered orally in the homes of participants.
MCT provided to participants, along with dietary intervention plan by a registered clinical nutritionist of 18 years experience.
Supplemental oils (MCT or control) delivered in-person at a pre-study information session, along with the diet plan.
Participants prescribed a ketogenic diet with a 4:1 lipid to non-lipid ratio with food self-administered based on the diet plan for the duration of the study (20 days). Males allocated a diet containing 2200 calories and females 1800 calories each equating to 80% calories from fat (including supplemental oils), 13-17% from protein and 3-6% from carbohydrate. Minor differences in carbohydrate and protein were due to the use of a protein intake of 1.4 g.kg-1 of (population-mean for male and female respectively) bm.day-1, in accordance with International Society of Sports Nutrition (ISSN) guidelines for optimal protein intake.
Participants were provided with a two-hour pre-study information session describing the diet and with a chance to ask questions and to receive the diet plan and supplemental oils. The pre-study information session was conducted by Cliff Harvey, a registered clinical nutritionist. This was further supported by 2 x 1-hour online workshops prior to study commencement for further clarification and for those unable to attend one of the other workshops (also run by CH - a registered clinical nutritionist). Throughout the study, participants were supported by the lead researcher, a registered clinical nutritionist, as needed. Adherence to the diet and supplementation was self-accountable, self-reported and not monitored by food diary or other means.
Intervention code [1] 295556 0
Treatment: Other
Comparator / control treatment
Control provided by a long chain triglyceride oil (sunflower) in the same dose, frequency and exposure as the intervention, applied to an identical ketogenic diet.
Control group
Placebo

Outcomes
Primary outcome [1] 299202 0
Time to nutritional ketosis
Nutritional ketosis defined as equal to or greater than 0.5 mmol/L of betahydroxybutyrate (BOHB).
BOHB measured daily on awakening (fasted) by finger-prick blood ketometer ('FreeStyle Optium' by Abbot Industries)
Timepoint [1] 299202 0
Daily for twenty days (twenty timepoints)
Secondary outcome [1] 326489 0
Symptoms of carbohydrate withdrawal. Measured by a symptoms questionnaire (Symptoms-Q) developed by the lead researcher. Taken daily upon waking. Sum of symptom scores will be analysed.
Timepoint [1] 326489 0
Daily for twenty days (twenty timepoints)
Secondary outcome [2] 326490 0
Mood, as measured by the Profile of Mood States, short-form questionnaire (POMS-SF). Taken daily upon waking (with other measures). Total mood disturbance score (TMDS) used for analysis.
Timepoint [2] 326490 0
Daily for twenty days (twenty timepoints)

Eligibility
Key inclusion criteria
30-50 years old
Minimum age
30 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 30 years of age or greater than 50 years of age. Obese, as defined by a BMI greater than 30. Those who have previously followed, or are currently following, a ketogenic diet. Diagnosed diabetic (type 1 or 2)
As the primary purpose of the study is to better understand induction times for ketosis, and symptoms of ketosis induction, those following a ketogenic diet currently (and therefore in ketosis) would be excluded.
Those who have previously followed a ketogenic diet may induce ketosis more rapidly and thereby confound results. There is a dearth of research in this area, but the primary researcher’s clinical observations indicate that it is likely that previous ketogenic diet use may encourage a faster induction into ketosis.

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)
Supplemental oils will be labelled by a third-party, unconnected to the trial from within AUT. Participants will be randomly allocated to receive either intervention or control oil and this will be provided in a sealed, opaque package at the pre-study information session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out by computer generated random sequencing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Pairwise comparisons between groups for all observed measures will be made for all timepoints and alaysed using magnitude based inferences. Time to nutritional ketosis will be analysed by Kaplan-Meier survival analysis with a log rank test to determine significance. Significance will be determined at p=<0.05
As a study contributing towards a masters thesis, sample size was determined by resources available.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/10/2015
Date of last participant enrolment
Anticipated
Actual
22/10/2015
Date of last data collection
Anticipated
30/11/2015
Actual
17/11/2015
Sample size
Target
30
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 8084 0
New Zealand
State/province [1] 8084 0
Auckland

Funding & Sponsors
Funding source category [1] 294246 0
University
Name [1] 294246 0
Auckland University of Technology (AUT)
Country [1] 294246 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
17 Antares Place, Rosedale 0632, North Shore, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 293080 0
None
Name [1] 293080 0
Address [1] 293080 0
Country [1] 293080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295669 0
AUT Ethics Committee (AUTEC)
Ethics committee address [1] 295669 0
46 Wakefield Street, Auckland 1010
Ethics committee country [1] 295669 0
New Zealand
Date submitted for ethics approval [1] 295669 0
30/09/2015
Approval date [1] 295669 0
07/10/2015
Ethics approval number [1] 295669 0
15/317

Summary
Brief summary
We invited interested people to participate in a research study about ketogenic diets.
The study “The Effects of Two Different Supplemental Oils on Keto-Adaptation and Symptoms of Carbohydrate Withdrawal” sought to help us better understand the effects of different food oils on achieving nutritional ketosis, and on symptoms of carbohydrate withdrawal (know as ‘Keto-Flu’). Non-obese, non-diabetic people aged between 30 and 50 years of age who had not previously followed a ketogenic diet and who were not current or former clients of either the lead researcher Cliff Harvey or Secondary Supervisor Mikki Williden were recruited. Participants followed a ketogenic diet prepared by Cliff Harvey for 20 days and recorded ketone levels (by way of a daily blood-prick test), along with a daily questionnaire and diary entry to evaluate a range of physical and psychological indicators of health. This study was completely voluntary and participants could withdraw at any time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68086 0
Mr Cliff Harvey
Address 68086 0
Holistic Performance Institute; 7 Ascension Place, Rosedale, Auckland 0632, New Zealand
Country 68086 0
New Zealand
Phone 68086 0
+64 22 016 9831
Fax 68086 0
Email 68086 0
[email protected]
Contact person for public queries
Name 68087 0
Mr Cliff Harvey
Address 68087 0
Holistic Performance Institute; 7 Ascension Place, Rosedale, Auckland 0632, New Zealand
Country 68087 0
New Zealand
Phone 68087 0
+64 9 478 3702
Fax 68087 0
Email 68087 0
[email protected]
Contact person for scientific queries
Name 68088 0
Mr Cliff Harvey
Address 68088 0
Holistic Performance Institute; 7 Ascension Place, Rosedale, Auckland 0632, New Zealand
Country 68088 0
New Zealand
Phone 68088 0
+64 9 478 3702
Fax 68088 0
Email 68088 0
[email protected]

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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