Effects of a short term Palaeolithic diet on fasting insulin, leptin and weight

ISRCTN ISRCTN47734717
DOI https://doi.org/10.1186/ISRCTN47734717
Secondary identifying numbers 1
Submission date
27/07/2016
Registration date
28/07/2016
Last edited
13/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Obesity and diabetes are on the rise, and have become a major health concern worldwide. There is a strong link between obesity and type two diabetes (a long term health condition where a person has difficulty controlling their blood sugar levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance)). There is some uncertainty and controversy with regard to the best diet for health and for the prevention of obesity and diabetes. The Paleolithic diet, sometimes called the “stone age diet”, is the diet that man ate for the first 95% of his existence. It involves eating the foods available during human evolution (root vegetables, leafy vegetables, fruits, nuts, eggs, lean meat, fish and shellfish), and equally importantly it involves cutting out grains, refined vegetable seed oils, refined sugar, dairy products, soya products and pulses and legumes (i.e. lentils, beans and peanuts). Studies have shown that this type of diet could have an effect on blood sugar levels and the levels of a hormone called leptin. Many "healthy" people have some degree of insulin resistance; the aim of this study was to see whether the insulin sensitivity of healthy volunteers might improve with a Palaeolithic diet, even if they were previously classified as having normal insulin sensitivity.

Who can participate?
Healthy adults.

What does the study involve?
Participants are encouraged to consume a Paleolithic diet for four weeks. This involves cutting out grains, refined vegetable seed oils, refined sugar, dairy products, soya products and pulses and legumes (i.e. lentils, beans and peanuts), and replacing them with fruit, vegetables, root vegetables, fish, lean meat, eggs and nuts. Participants can eat as much as they like of “allowed” foods, however must not have more than 30g of nuts or one potato per day. For non-Caucasian participants, if they feel they are unable to stick to the diet for four weeks, they are able to do so for two weeks instead. At the start of the study and then after the diet ends (two or four weeks), participants are weighed and provide blood samples so that their blood sugar, fat levels and leptin (hormone) levels can be measured. Before the blood tests, participants must not eat or drink anything except water for 12 hours.

What are the possible benefits and risks of participating?
Participants may benefit from weight loss in those who are overweight and improvements in insulin sensitivity in those with insulin resistance. There are no notable risks for participants, however some may feel discomfort or experience bruising from blood tests.

Where is the study run from?
The study takes place in participants homes and blood testing takes place at Blue Horizon Blood tests London (UK) and in home visits from the company Metropolis Healthcare Ltd (India)

When is the study starting and how long is it expected to run for?
April 2015 to July 2016

Who is funding the study?
Investigator initiated and funded (UK)

Who is the main contact?
Dr Madhvi Chanrai

Contact information

Dr Madhvi Chanrai
Public

Adamson Road
London
NW3 3HR
United Kingdom

Study information

Study designSingle-arm non-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typeOther
Participant information sheet http://thedoctorsdigest.com/participant-information-sheet-for-a-two-week-or-four-week-palaeolithic-diet-study/
Scientific titleEffects of a short term Palaeolithic diet on fasting leptin, insulin and weight in 41 healthy participants - an uncontrolled observational study
Study objectivesThe aim of this study is to look at the effects on insulin, leptin and weight after following a Palaeolithic diet for two weeks or four weeks.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInsulin resistance
InterventionAll participants are encouraged to consume a Paleolithic diet for four weeks. This involves exclusion of grains, refined vegetable seed oils, refined sugar, dairy products, soya products and legumes; and replacing these foods with fruit, vegetables, root vegetables, fish, lean meat, eggs and nuts. All other foods can be consumed in unlimited quantities, but with no more than 30g nuts an 1 potato per day.

If non-Caucasian participants felt they could not follow the diet for four weeks, they are given the option of following it for two weeks. Caucasians and participants with pre-diabetes are excluded from the two week study.
Intervention typeOther
Primary outcome measure1. Weight is measured in kg using a scale at home at baseline and 4 weeks (2 weeks for those following the 2 week diet)
2. Fasting insulin is measured using analysis of blood samples at baseline and 4 weeks (2 weeks for those following the 2 week diet)
3. Fasting leptin is measured using analysis of blood samples at baseline and 4 weeks (2 weeks for those following the 2 week diet)
Secondary outcome measures1. Fasting lipids is measured using analysis of blood samples at baseline and 4 weeks (2 weeks for those following the 2 week diet)
2. Fasting glucose is measured using analysis of blood samples at baseline and 4 weeks (2 weeks for those following the 2 week diet)
Overall study start date27/04/2015
Completion date06/07/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants41
Key inclusion criteria1. Male or female
2. Age range 18 to 80
3. Healthy
Key exclusion criteriaSerious medical conditions.
Date of first enrolment01/04/2015
Date of final enrolment28/06/2016

Locations

Countries of recruitment

  • England
  • India
  • United Kingdom

Study participating centres

Blue Horizon Blood tests London
76 Wimpole Street
London
W1G 9RT
United Kingdom
Metropolis Healthcare Ltd
-
Mumbai and Kolkata
-
India

Sponsor information

Dr Madhvi Chanrai
Other

Adamson Road
London
NW3 3HR
United Kingdom

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/06/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing plan

Editorial Notes

13/12/2019: No publications found, verifying study status with principal investigator.