Weight CyclingNCT05311462
An Observational Cohort Study to Obese Patients With Weight Cycling
An observational study of Weight Cycling and Obesity, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Medical nutritional weight loss was effective in reducing body weight and waist circumference and improving a range of cardiovascular disease risk factors in obese patients, with an average effective weight loss of 11.1 kg (about 13%) over 4 months in obese adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Weight Cycling, Obesity
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2022to 20 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Adult
Study population: Exposure group: Obese individuals with a history of weight cycling and successful weight loss with the nutritional intervention program after enrollment Control group: obese people with a history of previous weight cycle and failure to lose weight with nutritional intervention programs after enrollment Healthy control group: healthy volunteers of normal weight as a control population
Who may be able to join
- Normal weight (18.5 ≤ BMI < 24 kg/m2) or obese (28 ≤ BMI < 35 kg/m2);
- Aged 18 to 50 years old;
- Han nationality;
- Able to follow the weight-loss prescription;
- Able to sign consent independently;
- Definition of Weight cycling: Loss weight more than once in the past 3 years, and weight regain exceeds 5% or more of the baseline weight of losing weight.
Who cannot join
- Bodyweight has changed more than ±10% in the past year;
- Taking drugs known to affect body weight (orlistat, GLP-1 receptor agonists, etc.);
- Taking drugs known to affect glucolipid metabolism (such as sulfonylureas, biguanides, acarbose, or insulin) have been taken in the past 6 months or at present; Lipid-lowering drugs such as statins, bate, niacin, and ezetimibe; Diuretics, β -blockers and other antihypertensive drugs; Glucocorticoid, thyroid hormone, etc.);
- Women who are currently pregnant or nearly 3 months breastfeeding;
- With serious eating disorders or vigorous exercise to lose weight;
- Hard physical workers;
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- History of serious cardiovascular disease;
- Acute, chronic, or active gastrointestinal diseases;
- Serious systemic diseases;
- History of serious mental disorders;
- Cancer or active tumor;
- Secondary obesity or drug obesity patients: including hypothalamic obesity, pituitary obesity, hypercortisolism, and hypogonadism obesity;
- Severe liver dysfunction (ALT, AST, ALP, and TBil > the upper limit of 2.5 times reference value);
- Chronic kidney disease (eGFR < 60 mL/min/1.73 m2 or eGFR < 90 mL/min/1.73 m2 with proteinuria);
- Those who are considered by the researcher to be poor compliance or unable to complete this research well.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Exploration on Prevention and Treatment Mechanism of Obese Patient With Weight Cycling: An Investigator-initiated Single-center Cohort Study
Medical nutritional weight loss was effective in reducing body weight and waist circumference and improving a range of cardiovascular disease risk factors in obese patients, with an average effective weight loss of 11.1 kg (about 13%) over 4 months in obese adults. However, it was found through the follow-up visit that these subjects had lost only 5.8kg from baseline and regained about half of their weight (5.1 kg, 48%) after 21 months of weight-loss intervention. In this study, intestinal flora analysis was proposed to identify the causes of individual repeated weight loss failure, structure changes of weight cycling and the advantage species of flora, and explore different intestinal microbiota（microbial genomics） in ending weight loss, obesity-related genetic characteristics (SNPs loci and RNA seq), metabolite（metabolomics）and potential interaction between appetite-related hormones and weight cycling triggers. This study aimed to provide new insights for implementing personalized weight loss programs to improve the success rate of weight loss. The obese patients who failed to lose weight repeatedly were recruited from Peking Union Medical College Hospital.
Research Contents:(1) Comparison of anthropometric, biochemical, energy consumption, and intestinal microbiota related indicators between groups; (2) Genotyping to screen out differential SNPs loci;(3) Analysis of the interaction between genes and environmental factors in different metabolic types of obesity. (4) A group of healthy volunteers with normal weight as the healthy control group.
- Conditions
- Weight Cycling, Obesity
- Medical subject headings
- Weight Cycling, 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 success with history of weight cycling | High-protein diet for three months | |
| Weight-loss failure with history of weight cycling | High-protein diet for three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI changes
Both the height and weight will be measured with a standard instrument and recorded in meters and kilograms respectively，following a requirement of accurating to two decimal places. And the weight and height will be combined to report in a form of BMI in kg/m^2.The changes in BMI before and after the study will be expressed as mean ± SD.
Measured: Baseline time; after 1 months; after 45days; after 3 months; after 9 months；after1, 2, 3, 4 and 5 years
serum metabolome
Collection of peripheral blood (PB) serum for metabolomics analysis PB will be collected directly into serum separation tubes. The serum samples from this study will be profiled by a non-targeted LC-MS based metabolomics analysis.Metabolomics will be profiled by reverse-phase LC-MS using C8-pos (reverse-phase C8 chromatography/positive and negative ion mode that detects non-polar and weak-polar compounds) and HILIC-pos (hydrophilic interaction chromatography/positive ion mode that detects polar molecules). This study will compare and observe the type and concentration difference of serum metabolites before and after.
Measured: Baseline time; after 9 months; after1, 2, 3, 4 and 5 years
Faecal metagenomes changes
Patients will be requested to give stool samples that are collected in a sterile, sealed container and stored at -80 °C for strain-resolved metagenomic sequencing.DNA will be extracted from stool using the TIANamp Stool DNA Kit. We will conduct quality control using agarose gel electrophoresis. Metagenomics library will be constructed by NEXTflex Rapid DNA-Seq Kit (Illumina). The procedures included cluster generation, template hybridization, isothermal amplification, linearization, blocking and denaturation, and hybridization of the sequencing primers. We will observe differences in microbiome characteristics at various time points.
Measured: Baseline time; after 45 days; after 3 months; after 9 months;after1, 2, 3, 4 and 5 years
transcriptome changes
Peripheral blood of the subjects will be collected and used to extract PBMC.RNA extraction and transcriptome sequencing of the PBMC samples will be used for transcriptome sequencing.Total RNA will be extracted by using the RNAeasy kit according to the manufacturer's instructions. The purity, concentration, and integrity of total RNA will be checked using the NanoPhotometer spectrophotometer, the Qubit RNA Assay Kit in Qubit 2.0 Fluorometer and the RNA Nano 6000 Assay Kit of the Bioanalyzer 2100 System, respectively. Besides, RNA degradation and contamination will be monitored on 1% agarose gels. Sequencing libraries will be generated using the rRNA-depleted RNA by NEBNext UltraTM Directional RNA Library Prep Kit for Illumina and sequenced on an Illumina HiSeq 4000 platform. Transcriptome changes before and after the intervention will be observed to predict the outcome of weight-loss interventions.
Measured: Baseline time; after 3 months;after1, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start8 Apr 2022
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight CyclingStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chen, Peking Union Medical College Hospital
- Investigators
- Wei Chen, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311462
- Sponsor's protocol ID
- K3171
- Status last verified
- Jan 2025
- First submitted
- 15 Mar 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li W, Wang D, Chen H, Liu Y, Dong S, Sun M, Chen W. The relationship between psychological distress and weight maintenance in weight cycling: mediating role of eating behavior. BMC Public Health. 2024 Mar 26;24(1):894. doi: 10.1186/s12889-024-18349-5.
PubMed 38532390
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration on Prevention and Treatment Mechanism of Obese Patient With Weight Cycling: An Investigator-initiated Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT05311462
- Acronym / sponsor ID
- K3171
- Conditions
- Weight Cycling, Obesity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 5 Apr 2022 (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.
Medical nutritional weight loss was effective in reducing body weight and waist circumference and improving a range of cardiovascular disease risk factors in obese patients, with an average effective weight loss of 11.1 kg (about 13%) over 4 months in obese adults. However, it was found through the follow-up visit that these subjects had lost only 5.8kg from baseline and regained about half of their weight (5.1 kg, 48%) after 21 months of weight-loss intervention. In this study, intestinal flora analysis was proposed to identify the causes of individual repeated weight loss failure, structure changes of weight cycling and the advantage species of flora, and explore different intestinal microbiota（microbial genomics） in ending weight loss, obesity-related genetic characteristics (SNPs loci and RNA seq), metabolite（metabolomics）and potential interaction between appetite-related hormones and weight cycling triggers. This study aimed to provide new insights for implementing personalized weight loss programs to improve the success rate of weight loss. The obese patients who failed to lose weight repeatedly were recruited from Peking Union Medical College Hospital.
Research Contents:(1) Comparison of anthropometric, biochemical, energy consumption, and intestinal microbiota related indicators between groups; (2) Genotyping to screen out differential SNPs loci;(3) Analysis of the interaction between genes and environmental factors in different metabolic types of obesity. (4) A group of healthy volunteers with normal weight as the healthy control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-loss success with history of weight cycling | – | –High-protein diet for three months |
| Weight-loss failure with history of weight cycling | – | –High-protein diet for three months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Exposure group: Obese individuals with a history of weight cycling and successful weight loss with the nutritional intervention program after enrollment Control group: obese people with a history of previous weight cycle and failure to lose weight with nutritional intervention programs after enrollment Healthy control group: healthy volunteers of normal weight as a control population
Key inclusion criteria (6 listed)
- Normal weight (18.5 ≤ BMI < 24 kg/m2) or obese (28 ≤ BMI < 35 kg/m2);
- Aged 18 to 50 years old;
- Han nationality;
- Able to follow the weight-loss prescription;
- Able to sign consent independently;
Key exclusion criteria (15 listed)
- Bodyweight has changed more than ±10% in the past year;
- Taking drugs known to affect body weight (orlistat, GLP-1 receptor agonists, etc.);
- Taking drugs known to affect glucolipid metabolism (such as sulfonylureas, biguanides, acarbose, or insulin) have been taken in the past 6 months or at present; Lipid-lowering drugs such as statins, bate, niacin, and ezetimibe; Diuretics, β -blockers and other antihypertensive drugs; Glucocorticoid, thyroid hormone, etc.);
- Women who are currently pregnant or nearly 3 months breastfeeding;
- With serious eating disorders or vigorous exercise to lose weight;
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
BMI changes
Time frame: Baseline time; after 1 months; after 45days; after 3 months; after 9 months；after1, 2, 3, 4 and 5 years
Both the height and weight will be measured with a standard instrument and recorded in meters and kilograms respectively，following a requirement of accurating to two decimal places. And the weight and height will be combined to report in a form of BMI in kg/m^2.The changes in BMI before and after the study will be expressed as mean ± SD.
serum metabolome
Time frame: Baseline time; after 9 months; after1, 2, 3, 4 and 5 years
Collection of peripheral blood (PB) serum for metabolomics analysis PB will be collected directly into serum separation tubes. The serum samples from this study will be profiled by a non-targeted LC-MS based metabolomics analysis.Metabolomics will be profiled by reverse-phase LC-MS using C8-pos (reverse-phase C8 chromatography/positive and negative ion mode that detects non-polar and weak-polar compounds) and HILIC-pos (hydrophilic interaction chromatography/positive ion mode that detects polar molecules). This study will compare and observe the type and concentration difference of serum metabolites before and after.
Faecal metagenomes changes
Time frame: Baseline time; after 45 days; after 3 months; after 9 months;after1, 2, 3, 4 and 5 years
Patients will be requested to give stool samples that are collected in a sterile, sealed container and stored at -80 °C for strain-resolved metagenomic sequencing.DNA will be extracted from stool using the TIANamp Stool DNA Kit. We will conduct quality control using agarose gel electrophoresis. Metagenomics library will be constructed by NEXTflex Rapid DNA-Seq Kit (Illumina). The procedures included cluster generation, template hybridization, isothermal amplification, linearization, blocking and denaturation, and hybridization of the sequencing primers. We will observe differences in microbiome characteristics at various time points.
transcriptome changes
Time frame: Baseline time; after 3 months;after1, 2, 3, 4 and 5 years
Peripheral blood of the subjects will be collected and used to extract PBMC.RNA extraction and transcriptome sequencing of the PBMC samples will be used for transcriptome sequencing.Total RNA will be extracted by using the RNAeasy kit according to the manufacturer's instructions. The purity, concentration, and integrity of total RNA will be checked using the NanoPhotometer spectrophotometer, the Qubit RNA Assay Kit in Qubit 2.0 Fluorometer and the RNA Nano 6000 Assay Kit of the Bioanalyzer 2100 System, respectively. Besides, RNA degradation and contamination will be monitored on 1% agarose gels. Sequencing libraries will be generated using the rRNA-depleted RNA by NEBNext UltraTM Directional RNA Library Prep Kit for Illumina and sequenced on an Illumina HiSeq 4000 platform. Transcriptome changes before and after the intervention will be observed to predict the outcome of weight-loss interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 38532390Li W, Wang D, Chen H, Liu Y, Dong S, Sun M, Chen W. The relationship between psychological distress and weight maintenance in weight cycling: mediating role of eating behavior. BMC Public Health. 2024 Mar 26;24(1):894. doi: 10.1186/s12889-024-18349-5.
Related trials for Weight Cycling
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Recruiting
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
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.
Wei Chen, M.D. principal investigator
Peking Union Medical College 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 Weight Cycling and Obesity, run by Peking Union Medical College 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 6 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
BMI changes (time frame: Baseline time; after 1 months; after 45days; after 3 months; after 9 months；after1, 2, 3, 4 and 5 years). The study lists 4 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 NCT05311462, which also lists 1 linked publication.
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 14 Jan 2025.