Low-Carbohydrate Diet Intervention on Body Weight

Effect of Low-Carbohydrate or Restricted-Calories Diet 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.

Study Overview

• Status: Completed
• Conditions: Obesity; Over Weight
• Intervention / Treatment: Other: low carbohydrate diet; Other: Calories restricted diet

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Institute for Nutritional Sciences, Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: B; Subjects will be supplied with low carbohydrate diet for 12 weeks.	Other: low carbohydrate diet; Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
EXPERIMENTAL: A; Subjects will be supplied with calories restricted diet for 12 weeks	Other: Calories restricted diet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
waist circumference	12 weeks
LDL-C	12 weeks
HDL-C	12 weeks
blood pressure	12 weeks
body fat mass	12 weeks
body mass index	12 weeks
fast glucose	12 weeks
total cholesterol	12 weeks
triglyceride	12 weeks
urinary ketone	12 weeks

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (ESTIMATE): May 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 27, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: obesity; over weight
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: 30930081/C150502-LC