Overview

This trial is active, not recruiting.

Condition overweight: 25
Treatment 14/21 diet
Sponsor Assuta Hospital Systems
Start date July 2012
End date June 2015
Trial size 80 participants
Trial identifier NCT01991002, diet003

Summary

The scientific literature shows a quantitative relationship between diet combined with physical activity as a long term weight reduction modality and an important factor in weight maintenance.

Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term maintenance.

Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.
14/21 diet
Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.

Primary Outcomes

Measure
Weight reduction
time frame: 2 years

Secondary Outcomes

Measure
Anthropometric measurements
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Hebrew speaking 25

Additional Information

Official title Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program
Principal investigator Joshua Shemer, Prof.
Description An interventional part for a duration of 56 days and a follow-up period including monitoring of different parameters. Follow up session are set to 3, 6, 12 and 24 months from the end of the interventional period. Participants will be recruited in several rounds, each including up to 25 participants. Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.During the intervention period subjects will meet for walking. In addition, 30 minutes of aerobic exercise will be recommended 3 times/week.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Assuta Hospital Systems.