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NCT Number: NCT01358890

Low-Carbohydrate Diet Intervention on Body Weight

* 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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute for Nutritional Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • overweight/obese (BMI ≥24 kg/m2)

Exclusion criteria

  • Pregnancy or lactation;
  • Serum creatinine and blood urea nitrogen level beyond the clinical reference value;
  • alanine aminotransferase and aspartate aminotransferase beyond the reference levels;
  • Gastrointestinal problems that would prevent them from complying with the specified feeding conditions;
  • Received gastrointestinal surgery (except for appendicitis or hernia);
  • Severer CVD;
  • Active cancer;
  • Mental diseases, epilepsia or using anti-depression drugs;
  • Participating in other scientific studies within 3 months before the study.

Treatment and study plan

Low carbohydrate diet

Other

Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day

Calories restricted diet

Other

Total 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

Primary outcomes

  1. weight

    Time frame: 12 weeks

Secondary outcomes

  1. body fat mass

    Time frame: 12 weeks

  2. waist circumference

    Time frame: 12 weeks

  3. body mass index

    Time frame: 12 weeks

  4. fast glucose

    Time frame: 12 weeks

  5. total cholesterol

    Time frame: 12 weeks

  6. triglyceride

    Time frame: 12 weeks

  7. LDL-C

    Time frame: 12 weeks

  8. HDL-C

    Time frame: 12 weeks

  9. blood pressure

    Time frame: 12 weeks

  10. urinary ketone

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Harvard School of Public Health (HSPH)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 24, 2011
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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