Low-Carbohydrate Diet Intervention on Body Weight
Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFebruary 28, 2012
February 1, 2012
3 months
May 23, 2011
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight
12 weeks
Secondary Outcomes (10)
body fat mass
12 weeks
waist circumference
12 weeks
body mass index
12 weeks
fast glucose
12 weeks
total cholesterol
12 weeks
- +5 more secondary outcomes
Study Arms (2)
B
EXPERIMENTALSubjects will be supplied with low carbohydrate diet for 12 weeks.
A
EXPERIMENTALSubjects will be supplied with calories restricted diet for 12 weeks
Interventions
Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
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
Eligibility Criteria
You may qualify if:
- overweight/obese (BMI ≥24 kg/m2)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031, China
Related Publications (1)
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.
PMID: 34656033DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Lin, PhD
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 24, 2011
Study Start
May 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 28, 2012
Record last verified: 2012-02