Plain English Summary
Background and study aims
A diet which avoids processed foods, such as the Paleolithic diet, can result in weight loss but seems impossible in modern times where refined food is dominant. The aim of this study is to find out whether by excluding only a few refined foods involved in obesity, it is possible to overcome the limited food choices of the Paleolithic diet but still feel full and lose weight.
Who can participate?
Overweight and obese people
What does the study involve?
Participants eat a non-calorie restricted diet that excludes six refined foods (margarine, vegetable oils, butter, cream, processed meat, and sugary drinks) called the “1,2,3 diet”. Participants are weighed at the start of the study and at visits over a period of 2 years.
What are the possible benefits and risks of participating?
Not provided at time of registration (study completed)
Where is the study run from?
Hospital Antoine Beclère (France)
When is the study starting and how long is it expected to run for?
January 2011 to December 2015
Who is funding the study?
Hospital Antoine Beclère (France)
Who is the main contact?
Dr Rodi Courie
rodicourie@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rodi Courie
ORCID ID
Contact details
26 rue Dufrenoy
Paris
75116
France
+33 (0)680 578 144
rodicourie@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
123diet
Study information
Scientific title
A low-intensity diet that excludes six processed foods for a moderately obese population: long-term feasibility and effect on weight loss of the “1,2,3 diet”
Acronym
Study hypothesis
A diet devoid of food-processing procedure, such as the Paleolithic diet, is satiating and produces an important weight loss but seems impossible to implement in our modern times where refined food is dominant. This study investigated in humans whether by excluding only few refined foodstuffs implicated in obesity, it was possible to overcome the limited food choices of the Paleolithic diet but still restore early satiety and the subsequent weight loss.
Ethics approval
Human subject's committee in Biomedical Research at Bicêtre Hospital, October 2010
Study design
Two-year single-arm open-label exploratory study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Obesity, diabetes
Intervention
105 overweight subjects were assigned to an ad-libitum diet that excludes six refined foodstuffs (margarine, vegetable oils, butter, cream, processed meat, and sugary drinks) called the “1,2,3 diet”. Professional contact was minimal. The total duration of the study and follow-up was 2 years. Participants were suggested to come back for a first visit 1 month after the onset of the diet and every two to three months thereafter. There were no mandatory visits. Outcome measures were reported at 6, 12 and 24 months.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Body weight, measured by weighing patients without shoes to the nearest 0.5 kg on the same scale calibrated daily, at baseline and at each subsequent visit (6, 12 and 24 months) over a period of 2 years
Secondary outcome measures
The number of patients who lost more than 5% of their initial weight, measured by weighing patients without shoes to the nearest 0.5 kg on the same scale calibrated daily, at baseline and at each subsequent visit (6, 12 and 24 months) over a period of 2 years
Overall trial start date
05/01/2011
Overall trial end date
05/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Overweight and obese patients (body mass index (BMI) ≥ 25 Kg/m²) whose chief complaint was related to their excess weight
2. Age 18 to 74
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
105
Participant exclusion criteria
1. Pregnancy
2. Recent modifications to the usual diet
Recruitment start date
05/01/2011
Recruitment end date
26/04/2013
Locations
Countries of recruitment
France
Trial participating centre
Hospital Antoine Beclère
Outpatient endocrinology consultation of the Hepato-gastroenterology/Nutrition department
157 rue de la Porte de Trivaux
Clamart
92141
France
Sponsor information
Organisation
Hopital Antoine Belcère
Sponsor details
157 rue de la porte de Trivaux
clamart
92141
France
+33 (0)145 374 978
hadrien.tranchart@aphp.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hopital Antoine Belcère
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rodi Courie (rodicourie@gmail.com) and Dr Hadrien Tranchart (hadrien.trancahrt@aphp.fr)
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
1. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30034246 (added 23/01/2019)