Effect on weight loss of a diet inspired by traditional nutrition
| ISRCTN | ISRCTN49630431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49630431 |
| Secondary identifying numbers | 123diet |
- Submission date
- 03/05/2017
- Registration date
- 04/05/2017
- Last edited
- 23/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
26 rue Dufrenoy
Paris
75116
France
| Phone | +33 (0)680 578 144 |
|---|---|
| rodicourie@gmail.com |
Study information
| Study design | Two-year single-arm open-label exploratory study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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” |
| Study objectives | 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(s) | Human subject's committee in Biomedical Research at Bicêtre Hospital, October 2010 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 05/01/2011 |
| Completion date | 05/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 105 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Recent modifications to the usual diet |
| Date of first enrolment | 05/01/2011 |
| Date of final enrolment | 26/04/2013 |
Locations
Countries of recruitment
- France
Study participating centre
157 rue de la Porte de Trivaux
Clamart
92141
France
Sponsor information
Hospital/treatment centre
157 rue de la porte de Trivaux
clamart
92141
France
| Phone | +33 (0)145 374 978 |
|---|---|
| hadrien.tranchart@aphp.fr | |
"ROR" |
https://ror.org/04sb8a726 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/07/2018 | 23/01/2019 | Yes | No |
Editorial Notes
23/01/2019: Publication reference added
12/07/2017: Internal edit.
