Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/05/2017
Date assigned
04/05/2017
Last edited
12/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal edit.