Overweight: 25 <BMI <30 Clinical Trial
Official title:
Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment