Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002406306 Date of Registration: 06/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of a high fat low carb diet on physiological function
Official scientific title The effect of a ketogenic diet on thyroid function, cardiovascular health and sleep and cognition
Brief summary describing the background and objectives of the trial Diets low in carbohydrate and high in fat, or ketogenic diets (KD), are conventionally used to to treat epilepsy and neurodegenerative disorders 33, 37, but have been relatively popular for weight-loss since the 1860¿s 7. The fundamental principle of the KD is severe restriction of dietary carbohydrate consumption, with a concurrent increase in dietary fat to compensate for the energy deficit, resulting in the promotion of lipid oxidation to produce ketones as an energy source (as opposed to glucose), and thus, a metabolic state of nutritional ketosis (REF). There are inconsistencies in the literature regarding the physiological and health benefits of the KD compared with the current recommended diet that is high in carbohydrate and low in fat (HCLF), particularly in the general population. The majority of studies investigating the KD have been done in overweight/obese populations, with or without diabetes mellitus and/or insulin resistance, and importantly, most studies are not randomized controlled-crossover trials and do not control for total caloric intake. In particular, data on the effects of diet on cognitive and thyroid function, metabolic rate, sleep, and cardiovascular health (particularly with regards to inflammation), in healthy individuals are lacking.This study will aim to assess the effects of a KD compared to a HCLF diet on sleep, BMR, and measures of thyroid function, cardiovascular health and cognitive function (including markers of inflammation), in a healthy adult population.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diet,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2016
Actual trial start date 01/08/2017
Anticipated date of last follow up 30/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a randomisation table created by a computer software program Sealed envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HFLC Every day 3 weeks Diet high in fat and low in carbohydrate 20
Control Group HCLF Every day 3 weeks Diet high in carbohydrates and low in fat 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Men and women Normal BMI Chronic illness Depression Sleep disorders Overweight BMI Metabolic disease Cardiovascular disease 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/08/2015 Human Research Ethics Committee (medical), University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
PVT building, 2nd Floor, Cnr York Road and Princess of Wales Terrace Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in sleep quality, cognitive function and basal metabolic rate Baseline, before the start of each (3 week) diet and at the end of each diet.
Secondary Outcome Change in markers of inflammation and cardiovascular health status Baseline, before the start of each (3 week) diet and at the end of each diet
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Movement Physiology Research Laboratory, School of Physiology, University of the Witwatersrand 7 York Road Johannesburg 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
N/A
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Movement Physiology Research Laboratory 6th Floor Medical School, 7 York Road, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Rebecca Meiring 7 York Road, Parktown Johannesburg 2193 South Africa
Stella Iacovides 7 York Road, Parktown Johannesburg 2193 South Africa
Bronwyn Paterson 7 York Road, Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stella Iacovides Stella.Iacovides@wits.ac.za +27117172265 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer
Role Name Email Phone Street address
Public Enquiries Bronwyn Paterson bronpat@gmail.com +27117172363 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Postgraduate student
Role Name Email Phone Street address
Scientific Enquiries Stella Iacovides Stella.Iacovides@wits.ac.za +27117172265 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information