Weight LossNCT06373887
The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs)
A study testing plant-based Low carbohydrate diet and plant-based Low low fat diet in people with Weight Loss, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single… Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- plant-based Low carbohydrate diet and plant-based Low low fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- 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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with BMI >=24 overweight and obesity without chronic disease or medication use.
Who cannot join
- a) Medication history of diabetes, hypertension, dyslipidemia, and cardiovascular diseases within two months.
- Bodyweight change within three months before the study. (+4kg). c) Participate in weight loss programs in the preceding 12 months. d) Use ABX, PPI, NSAID, laxatives, oral contraceptives, and antipsychotics within two months.
- Previous operations history for managing obesity (bariatric procedures and gastric bypass operation).
- Current smoking: at least 20 monthly cigarettes for over half a year. g) Alcohol consumption (> two glasses per day). h) Pregnancy, breastfeeding, chronic kidney dis-ease, autoimmune, viral chronic diseases (hepatitis C, B, HIV, etc.), and neoplastic diseases.
- Consumption of vegetarian or unusual diets. The Institutional Review Board approved all study protocols at TVGH.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Beitou District, 11217
Chun-Ying Wu, +886-28712121 ext. 4190, chptaiwan07@gmail.com
HSIAO-PING CHEN, +886-28712121 ext. 4190, chptaiwan07@gmail.com
About this study
In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes.
Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue .
Read the detailed description
Many studies have shown that dysbiosis of gut microbiota is related to obesity and metabolic diseases4. Since there are many clinical guidelines for weight loss dietary recommendations that have been developed, successful long-term weight loss was still a challenge due to the personal variation of multi-omics markers at baseline and distinct diet-host-microbiome interaction1,2. A recent study2 related to successful long-term weight loss has found that the baseline microbiota composition and energy utilized patterns are related to the efficacy of long-term weight loss; The population with higher respiratory quotient (RQ) at baseline had significantly more weight loss when participating in a low-carb weight loss diet, suggesting that individuals with carbs as their main energy source had greater weight loss benefits when reducing carb sources. In our previous study, we also found that after the intervention of a low-carb diet (LCD), the groups with better weight loss results had higher diversity at the baseline, and the groups with better weight loss showed more active carbohydrate degradation using gut metabolic modules (GMMs) analysis. In contrast, one study5 showed an increased abundance of the genus (Dialister) encoding carbohydrate-active enzymes gene was associated with unsuccessful body weight loss when intervening with a weight-loss diet enriched with carbohydrates (Volumetric Diet). According to a recent study2 comparing a low-carb diet (LCD) and low-fat diet (LFD) for long-term weight loss, the LCD with a higher ratio of monounsaturated fatty acid (MUFA): saturated fatty acid (SFA) showed a better weight-loss response, while LFD with whole grain carbohydrate had better weight-loss response than refined grain carbohydrate. However, the weight loss efficacy between two diet arm within people with different carb degradation activities at the baseline was still unclear.
So far, there are no studies that use microbiota GMMs analysis before deciding which diet to intervene. Therefore, our study aims to investigate whether pre-examination and then intervention can bring benefits to weight loss efficacy.
Before the two dietary interventions, fecal microbiota analysis will be conducted to understand the metabolic activity of carbohydrates and then determine whether to enter the low-carbohydrate group or the low-fat group. The participants in this study will be divided into two groups: one group will have their gut microbiota measured before receiving dietary treatment, while the other group will be randomly assigned to one of the two dietary groups. Finally, the weight loss benefits and changes in gut microbiota and related biochemical data between the two groups will be compared.
- Conditions
- Weight Loss
- Being tested
- plant-based Low carbohydrate diet, plant-based Low low fat diet
- Keywords
- Gut Microbiome, Weight Loss Diet
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based Low carbohydrate dietDietary supplement
In the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight.
plant-based Low low fat dietDietary supplement
In the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight.
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate diet | Experimental | Not described Receives: Dietary Supplement: plant-based Low carbohydrate diet |
| Low fat diet arm | Active comparator | Not described Receives: Dietary Supplement: plant-based Low low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight loss/fat mass loss
Measured: 2 weeks to 2 months
Secondary outcomes (1)
microbiota change
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start10 Apr 2024 (estimated)
- Primary completion29 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373887
- Sponsor's protocol ID
- 2023-09-005A
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs)
- ClinicalTrials.gov ID
- NCT06373887
- Acronym / sponsor ID
- 2023-09-005A
- Conditions
- Weight Loss
- Keywords
- Gut Microbiome, Weight Loss Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 2024 (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.
In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes.
Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue .
Detailed description
Many studies have shown that dysbiosis of gut microbiota is related to obesity and metabolic diseases4. Since there are many clinical guidelines for weight loss dietary recommendations that have been developed, successful long-term weight loss was still a challenge due to the personal variation of multi-omics markers at baseline and distinct diet-host-microbiome interaction1,2. A recent study2 related to successful long-term weight loss has found that the baseline microbiota composition and energy utilized patterns are related to the efficacy of long-term weight loss; The population with higher respiratory quotient (RQ) at baseline had significantly more weight loss when participating in a low-carb weight loss diet, suggesting that individuals with carbs as their main energy source had greater weight loss benefits when reducing carb sources. In our previous study, we also found that after the intervention of a low-carb diet (LCD), the groups with better weight loss results had higher diversity at the baseline, and the groups with better weight loss showed more active carbohydrate degradation using gut metabolic modules (GMMs) analysis. In contrast, one study5 showed an increased abundance of the genus (Dialister) encoding carbohydrate-active enzymes gene was associated with unsuccessful body weight loss when intervening with a weight-loss diet enriched with carbohydrates (Volumetric Diet). According to a recent study2 comparing a low-carb diet (LCD) and low-fat diet (LFD) for long-term weight loss, the LCD with a higher ratio of monounsaturated fatty acid (MUFA): saturated fatty acid (SFA) showed a better weight-loss response, while LFD with whole grain carbohydrate had better weight-loss response than refined grain carbohydrate. However, the weight loss efficacy between two diet arm within people with different carb degradation activities at the baseline was still unclear.
So far, there are no studies that use microbiota GMMs analysis before deciding which diet to intervene. Therefore, our study aims to investigate whether pre-examination and then intervention can bring benefits to weight loss efficacy.
Before the two dietary interventions, fecal microbiota analysis will be conducted to understand the metabolic activity of carbohydrates and then determine whether to enter the low-carbohydrate group or the low-fat group. The participants in this study will be divided into two groups: one group will have their gut microbiota measured before receiving dietary treatment, while the other group will be randomly assigned to one of the two dietary groups. Finally, the weight loss benefits and changes in gut microbiota and related biochemical data between the two groups will be compared.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions.
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet | Experimental | Dietary Supplement: plant-based Low carbohydrate diet |
| Low fat diet arm | Active comparator | Dietary Supplement: plant-based Low low fat diet |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with BMI >=24 overweight and obesity without chronic disease or medication use.
Key exclusion criteria (5 listed)
- a) Medication history of diabetes, hypertension, dyslipidemia, and cardiovascular diseases within two months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plant-based Low carbohydrate dietIn the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight. | Dietary supplement | Low carbohydrate diet |
| plant-based Low low fat dietIn the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight. | Dietary supplement | Low fat diet arm |
Primary outcome
Body weight loss/fat mass loss
Time frame: 2 weeks to 2 months
1 secondary outcome
microbiota change
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant-based Low carbohydrate diet and plant-based Low low fat diet in people with Weight Loss, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 5 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 18 Apr 2024. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight loss/fat mass loss (time frame: 2 weeks to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.