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

Primary Purpose

Overweight

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
diet nutrition bar
energy-restricted diet
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Very Low Carbohydrate Diet, Overweight/obese

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    energy-restricted diet

    diet nutrition bar

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 26, 2014
    Last Updated
    November 2, 2014
    Sponsor
    Southern Medical University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02283151
    Brief Title
    The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China
    Official Title
    The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southern Medical University, China

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    Very Low Carbohydrate Diet, Overweight/obese

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    energy-restricted diet
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    diet nutrition bar
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    diet nutrition bar
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    energy-restricted diet
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    body composition
    Description
    body composition included weight, body mass index, body fat, body fat percentage, visceral fat, waist-to-hip ratio
    Time Frame
    before intervention and after 12 weeks' intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    68 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jia Sun, PhD.
    Organizational Affiliation
    Southern Medical University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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