Clinical trial NCT01358890: Low-Carbohydrate Diet Intervention on Body Weight
Official title: Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Over Weight
Obesity
Keywords: over weight
obesity
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2011-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: weight
timeFrame: 12 weeks
Secondary outcomes:
measure: body fat mass
timeFrame: 12 weeks
measure: waist circumference
timeFrame: 12 weeks
measure: body mass index
timeFrame: 12 weeks
measure: fast glucose
timeFrame: 12 weeks
measure: total cholesterol
timeFrame: 12 weeks
measure: triglyceride
timeFrame: 12 weeks
measure: LDL-C
timeFrame: 12 weeks
measure: HDL-C
timeFrame: 12 weeks
measure: blood pressure
timeFrame: 12 weeks
measure: urinary ketone
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute for Nutritional Sciences, Chinese Academy of Sciences
state: Shanghai
Study officials:
affiliation: Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
name: Xu Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma Y, Sun Y, Sun L, Liu X, Zeng R, Lin X, Li Y. Effects of gut microbiota and fatty acid metabolism on dyslipidemia following weight-loss diets in women: Results from a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5511-5520. doi: 10.1016/j.clnu.2021.09.021. Epub 2021 Sep 23.