Overweight or ObesityNCT04207879
Modified Atkins Diet for Overweight and Obesity
An observational study of Overweight or Obesity, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
The aim of the study is to investigate dynamic changes in biochemical metabolism, gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study is conducted in Shijiazhuang, a city in Northen China. Eligible participants are residents in this area and aged 18-55 years old, who are on a modified Atkins diet aiming to lose weight.
Who may be able to join
- 18-55 years old;
- BMI > 23.9kg/m2;
- being willing and able to receive guidelines to a modified Atkins diet;
- signed informed consent.
Who cannot join
- patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
- patients with malignant tumor;
- pregnant and lactating women;
- those with recent relocation plans.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Profiling of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet: a Prospective Cohort Study
The aim of the study is to investigate dynamic changes in biochemical metabolism, gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets.
Read the detailed description
The mechanisms of obesity are complex, involved in genes, environment, life style, and systemic and adipose tissue inflammation. Dysbiosis of gut microbiome is considered to make a difference in obesity. On the other hand, both long-term and short-term dietary interventions can induce changes in the body composition and structure and function of gut microbiome. However, it is not really clear how gut microbiome changes along with weight loss in overweight or obese.
In the present study, investigators aim to characterize the gut microbiome among overweight or obese participants on a modified Atkins diets. The stool and blood samples were collected by an interval of every 5% and 10% of weight loss, respectively. Data collecting mainly covers: 1) body composition analysis ; 2) obesity related biochemical metabolism; 3) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques; 4) metabolomics of serum and gut microbiome; 5) measurement of physical activity and diets using questionnaires.
- Conditions
- Overweight or Obesity
- Keywords
- modified Atkins Diet, Overweight, Obesity, Gut Microbiome, Body composition
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| weight loss group | Dynamic changes in body composition, biochemical metabolomics and gut microbiome will be reported among overweight and obese patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes of gut microbiome
The stool sample will be collected by an interval of each 5% weight loss that participants experienced. Fecal microbiota will be analyzed by 16S rRNA gene sequencing technique.
Measured: 36 months
Dynamic changes in faecal metabolomics
For participants achieving each 10% weight loss, targeting metabonomics will be applied to identify the abundances of faecal metabolites (e.g. short-chain fatty acids, amino acids and carbohyrates) using validated mass spectrometry methods.
Measured: 36 months
Secondary outcomes (7)
Dynamic changes of body mass index
Weight and height will be combined to report BMI in kg/m^2.
Measured: 36 months
Dynamic changes of body fat
As a body composition parameter, body fat will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
Measured: 36 months
Dynamic changes of muscle mass
Muscle mass will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
Measured: 36 months
Dynamic changes of blood lipids
For participants achieving each 10% weight loss, intravenous serum will be collected and the parameters which can reflect the lipids metalism (such as triglyceride, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol ) will be measured by automatic biochemical analyzer.
Measured: 36 months
Dynamic changes of fasting blood glucose
For participants achieving each 10% weight loss, intravenous serum will be collected and fasting blood glucose will be measured by automatic biochemical analyzer.
Measured: 36 months
Dynamic changes of homocysteine
For participants achieving each 10% weight loss, intravenous serum will be collected and homocysteine will be measured by automatic biochemical analyzer.
Measured: 36 months
Dynamic changes of blood pressure
For participants achieving each 10% weight loss, blood pressure will be measured by the standard electronic sphygmomanometer.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2022
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake University
- Responsible party
- Principal investigator, Dan Yu, PhD, Hebei Medical University Third Hospital
- Investigators
- Hai-Ling Di, MD, Study director, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207879
- Sponsor's protocol ID
- YD_20190301
- Status last verified
- Jan 2022
- First submitted
- 4 Dec 2019
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data might be made available 24 months after completion of the study. Requests for access to the study data can be submitted via email to the principal investigator yudan20122013@163.com, and proposals are required to be attached for approval.
Publications
Lin BY, Lin WD, Huang CK, Hsin MC, Lin WY, Pryor AD. Changes of gut microbiota between different weight reduction programs. Surg Obes Relat Dis. 2019 May;15(5):749-758. doi: 10.1016/j.soard.2019.01.026. Epub 2019 Jan 31.
PubMed 30935838Frost F, Storck LJ, Kacprowski T, Gartner S, Ruhlemann M, Bang C, Franke A, Volker U, Aghdassi AA, Steveling A, Mayerle J, Weiss FU, Homuth G, Lerch MM. A structured weight loss program increases gut microbiota phylogenetic diversity and reduces levels of Collinsella in obese type 2 diabetics: A pilot study. PLoS One. 2019 Jul 18;14(7):e0219489. doi: 10.1371/journal.pone.0219489. eCollection 2019.
PubMed 31318902Heianza Y, Sun D, Smith SR, Bray GA, Sacks FM, Qi L. Changes in Gut Microbiota-Related Metabolites and Long-term Successful Weight Loss in Response to Weight-Loss Diets: The POUNDS Lost Trial. Diabetes Care. 2018 Mar;41(3):413-419. doi: 10.2337/dc17-2108. Epub 2018 Jan 5.
PubMed 29305401Yu D, Chen W, Zhang J, Wei L, Qin J, Lei M, Tang H, Wang Y, Xue S, Dong J, Chen Y, Xie L, Di H. Effects of weight loss on bone turnover, inflammatory cytokines, and adipokines in Chinese overweight and obese adults. J Endocrinol Invest. 2022 Sep;45(9):1757-1767. doi: 10.1007/s40618-022-01815-5. Epub 2022 May 30.
PubMed 35635643
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Profiling of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04207879
- Acronym / sponsor ID
- YD_20190301
- Conditions
- Overweight or Obesity
- Keywords
- modified Atkins Diet, Overweight, Obesity, Gut Microbiome, Body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Collaborators
- Westlake University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate dynamic changes in biochemical metabolism, gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets.
Detailed description
The mechanisms of obesity are complex, involved in genes, environment, life style, and systemic and adipose tissue inflammation. Dysbiosis of gut microbiome is considered to make a difference in obesity. On the other hand, both long-term and short-term dietary interventions can induce changes in the body composition and structure and function of gut microbiome. However, it is not really clear how gut microbiome changes along with weight loss in overweight or obese.
In the present study, investigators aim to characterize the gut microbiome among overweight or obese participants on a modified Atkins diets. The stool and blood samples were collected by an interval of every 5% and 10% of weight loss, respectively. Data collecting mainly covers: 1) body composition analysis ; 2) obesity related biochemical metabolism; 3) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques; 4) metabolomics of serum and gut microbiome; 5) measurement of physical activity and diets using questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weight loss group | – | –Dynamic changes in body composition, biochemical metabolomics and gut microbiome will be reported among overweight and obese patients. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study is conducted in Shijiazhuang, a city in Northen China. Eligible participants are residents in this area and aged 18-55 years old, who are on a modified Atkins diet aiming to lose weight.
Key inclusion criteria (4 listed)
- 18-55 years old;
- BMI > 23.9kg/m2;
- being willing and able to receive guidelines to a modified Atkins diet;
- signed informed consent.
Key exclusion criteria (4 listed)
- patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
- patients with malignant tumor;
- pregnant and lactating women;
- those with recent relocation plans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic changes of gut microbiome
Time frame: 36 months
The stool sample will be collected by an interval of each 5% weight loss that participants experienced. Fecal microbiota will be analyzed by 16S rRNA gene sequencing technique.
Dynamic changes in faecal metabolomics
Time frame: 36 months
For participants achieving each 10% weight loss, targeting metabonomics will be applied to identify the abundances of faecal metabolites (e.g. short-chain fatty acids, amino acids and carbohyrates) using validated mass spectrometry methods.
7 secondary outcomes
Dynamic changes of body mass index
Time frame: 36 months
Dynamic changes of body fat
Time frame: 36 months
Dynamic changes of muscle mass
Time frame: 36 months
Dynamic changes of blood lipids
Time frame: 36 months
Dynamic changes of fasting blood glucose
Time frame: 36 months
Dynamic changes of homocysteine
Time frame: 36 months
Dynamic changes of blood pressure
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 30935838Lin BY, Lin WD, Huang CK, Hsin MC, Lin WY, Pryor AD. Changes of gut microbiota between different weight reduction programs. Surg Obes Relat Dis. 2019 May;15(5):749-758. doi: 10.1016/j.soard.2019.01.026. Epub 2019 Jan 31.
- Background: PubMed 31318902Frost F, Storck LJ, Kacprowski T, Gartner S, Ruhlemann M, Bang C, Franke A, Volker U, Aghdassi AA, Steveling A, Mayerle J, Weiss FU, Homuth G, Lerch MM. A structured weight loss program increases gut microbiota phylogenetic diversity and reduces levels of Collinsella in obese type 2 diabetics: A pilot study. PLoS One. 2019 Jul 18;14(7):e0219489. doi: 10.1371/journal.pone.0219489. eCollection 2019.
- Background: PubMed 29305401Heianza Y, Sun D, Smith SR, Bray GA, Sacks FM, Qi L. Changes in Gut Microbiota-Related Metabolites and Long-term Successful Weight Loss in Response to Weight-Loss Diets: The POUNDS Lost Trial. Diabetes Care. 2018 Mar;41(3):413-419. doi: 10.2337/dc17-2108. Epub 2018 Jan 5.
- Derived from this study: PubMed 35635643Yu D, Chen W, Zhang J, Wei L, Qin J, Lei M, Tang H, Wang Y, Xue S, Dong J, Chen Y, Xie L, Di H. Effects of weight loss on bone turnover, inflammatory cytokines, and adipokines in Chinese overweight and obese adults. J Endocrinol Invest. 2022 Sep;45(9):1757-1767. doi: 10.1007/s40618-022-01815-5. Epub 2022 May 30.
- Individual participant dataSharing planned: Yes. The data might be made available 24 months after completion of the study. Requests for access to the study data can be submitted via email to the principal investigator yudan20122013@163.com, and proposals are required to be attached for approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hai-Ling Di, MD study director
Hebei Medical University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight or Obesity, run by Hebei Medical University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes of gut microbiome (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207879, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.