Skip to content

The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China

The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02283151
Enrollment
98
Registered
2014-11-05
Start date
2013-06-30
Completion date
2013-12-31
Last updated
2014-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

Very Low Carbohydrate Diet, Overweight/obese

Brief summary

The study was designed to investigate the effects of a very low carbohydrate diet (VLCD) intervention on weight control in overweight/obese patients in China.All the subjects were randomly assigned to experiment group and control group. The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet). The control group was given an energy-restricted diet.The energy-restricted diet (ER diet) was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).

Detailed description

121 obese or overweight patients were enrolled in the study and 23 patients were dropped out (43 male, 55 female, aged≥18 years, BMI≥24 kg/m2) from the outpatient clinic of endocrinology and metabolism department of Southern Medical University Affiliated ZhuJiang Hospital. All the subjects were randomly assigned to experiment group and control group. The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet). Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake \< 20g/d). All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar (106 Kcal: 2.8 g carbohydrate, 11.2 g protein and 5.6 g fat; Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (\<200 kcal), and 50 g protein from meat (i.e., beef, lean pork, skinned chicken, fish) at lunch and dinner. Supplementation of multivitamins and minerals was provided per day. The energy-restricted diet (ER diet) was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d). Subjects were also encouraged to drink at least 1.8 litres of water per day, and asked to maintain their habitual level of physical activity. Compliance with the diet and physical activity level was checked at weekly visits.

Interventions

DIETARY_SUPPLEMENTdiet nutrition bar

The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet). Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake \< 20g/d). All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar(Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (\<200 kcal), and 50 g protein from meat at lunch and dinner. Supplementation of multivitamins and minerals was provided per day.

The control group was given an energy-restricted diet (ER diet). Energy-restricted diet was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).

Sponsors

Southern Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No

Inclusion criteria

* overweight or obese healthy volunteers (43 male, 55 female, aged≥18years, BMI≥24 kg/m2)

Exclusion criteria

* pregnant or plan for pregnant * lactation or postmenopausal women * use of any prescription medication in previous 2 months * had any weight loss diet or pill during the past 6 months * consuming\>20 g/day of alcohol * tobacco use within 6 month * cardiovascular or endocrine disease history * hypertension history or current elevated blood pressure (systolic blood pressure (SBP): ≥150 mmHg; diastolic blood pressure (DBP)≥90 mmHg; current treatment for hypertension) * diabetes mellitus * acute or chronic infections * hepatopathy, kidney disease, gastrointestinal disease or any other acute or chronic diseases requiring treatment.

Design outcomes

Primary

MeasureTime frameDescription
body compositionbefore intervention and after 12 weeks' interventionbody composition included weight, body mass index, body fat, body fat percentage, visceral fat, waist-to-hip ratio

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026