Clinical Trials Directory

Trials / Completed

CompletedNCT01358890

Low-Carbohydrate Diet Intervention on Body Weight

Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Chinese Academy of Sciences · Other Government
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Not accepted

Summary

* The primary aim of this study is to determine the adherence of low- carbohydrate among Chinese. * Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits.

Detailed description

Obesity is a well established risk factor for type 2 diabetes mellitus, hypertension, dyslipidemia and cardiovascular disease. Along with rapid nutritional and lifestyle transition featured as increased energy dense diet intake and reduced physical activity, the prevalence of obesity has reached epidemic level and affected more than 70 million Chinese adults nowadays. Previous studies suggested that low-carbohydrate diet was an effective and safe way to lose weight and had potential benefit on lipids profiles. However, it is still unknown whether this diet can be feasible to control the epidemic of obesity and its related metabolic diseases among Chinese, whose carbohydrate consumption contribute approximately 55% of total energy intake. Therefore, the aim of this pilot study is to investigate the adherence and effectiveness of two weight-loss diets among Chinese. This will be a randomized, controlled clinical trial. A total of 50 overweight or obese nurse assistants will be randomly assigned to receive a low-carbohydrate diet or a traditional high-carbohydrate Chinese but restricted-calories diet for 12 weeks. The adherence of study protocol and effects of the two diets on body weight, waist circumference, body fat, fasting glucose and lipid profile will be evaluated.

Conditions

Interventions

TypeNameDescription
OTHERlow carbohydrate dietDietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
OTHERCalories restricted dietTotal energy intake is restricted to 1200 kcal/day for women. Energy from carbohydrate, protein and fat will be kept to approximate 55%, 20% and 25%, respectively. Moreover, saturated fat and dietary cholesterol are restricted to at most 10% energy and 300 mg/day, respectively

Timeline

Start date
2011-05-01
Primary completion
2011-08-01
Completion
2011-08-01
First posted
2011-05-24
Last updated
2012-02-28

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01358890. Inclusion in this directory is not an endorsement.