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

NCT02283151 | Completed Phase 2

• 1 other identifier: Grant No.81300689
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Overweight

Keywords

Very Low Carbohydrate Diet; Overweight/obese

Outcome Measures

Primary Outcomes (1)

• body composition

  body composition included weight, body mass index, body fat, body fat percentage, visceral fat, waist-to-hip ratio

  before intervention and after 12 weeks' intervention

Study Arms (2)

energy-restricted diet

OTHER

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). Supplementation of multivitamins and minerals was provided per day.

Other: energy-restricted diet

diet nutrition bar

EXPERIMENTAL

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). Carbohydrate-rich foods, such as white rice, steamed bread and tubers, were substituted with fish, poultry and plant oil. 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.

Dietary Supplement: diet nutrition bar

Interventions

diet nutrition bar DIETARY_SUPPLEMENT

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.

diet nutrition bar

energy-restricted diet OTHER

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).

energy-restricted diet

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Medical University, China: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jia Sun, PhD.

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: November 5, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 5, 2014

Record last verified: 2014-10