Postprandial HyperglycemiaNCT05161182
Westlake N-of-1 Trials for Macronutrient Intake 2 ( WE-MACNUTR 2)
A study testing High fat, low carbohydrate diet and Low fat, high carbohydrate diet in people with Postprandial Hyperglycemia and Metabolic Disorder, Glucose, run by Westlake University at 1 site in China.
Trial summary
Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Metabolic Disorder, Glucose
- What is being tested?
- High fat, low carbohydrate diet and Low fat, high carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2021to 19 Nov 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants have completed WE-MACNUTR trial in 2019
- Participants have no traveling plans within 1 months
- Participants are able and willing to comply with the study protocol and provide informed consent
Who cannot join
- Refuse or are unable to provide informed consent to participate in the study
- Have long-term gastrointestinal diseases and take daily relevant medications
- Have taken antibiotics in the last 2 weeks
- Have type 2 diabetes and are taking medications or other treatments
- Have chronic or acute liver disease and are taking medications or other treatments
- Have cardiovascular diseases and are taking medications or other treatments
Show all 12Show fewer
- Have kidney disease and are taking medications
- Suffer from chronic anxiety or depression, or other critical neuronal disorder and/or history of relevant medication
- Are pregnant or lactating, or are planning to be pregnant in the next 3 months
- Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa)
- Are vegan, or unwilling to consume foods provided in the study
- Have history of alcohol or drug addiction, or smoke above 15 cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2
Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. The experimental diets are isocaloric high fat, low carbohydrate (HF-LC) or low fat, high carbohydrate (LF-HC). With standardized intervention and strictly controlled eating behaviors, the WE-MACNUTR study identifies specific HC-responders and HF-responders in terms of postprandial glucose response.
This is a follow-up study offered to participants who have completed the WE-MACNUTR study in 2019. Volunteers will be asked to participate in four 5-d periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned. Participants will be asked to provide a fasted blood sample and to collect fecal, urine and saliva samples at each visits.
Read the detailed description
This study is a two arm dietary intervention study. Participants will be recruited from the WE-MACNUTR study based on the defined inclusion and exclusion criteria. The study duration will last up to 21 days.
Volunteers will be asked to participate in four 5-day periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned.
Participants will enter the study on a usual (washout) diet and will have a 5-day run in period for baseline data collection. Participants will be asked to follow dietary guidance and consumed a healthy and balanced diet during this period.
- Being tested
- High fat, low carbohydrate diet, Low fat, high carbohydrate diet
- Keywords
- Personalized Nutrition, Glucose Metabolism, Gut Microbiota
- Medical subject headings
- Hyperglycemia, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat, low carbohydrate dietOther
Also called HF-LC
Throughout the 5-day intervention, participants are provided with a high fat, low carbohydrate (HF-LC) diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25%, respectively.
Low fat, high carbohydrate dietOther
Also called LF-HC
Throughout the 5-day intervention, participants are provided with a low fat, high carbohydrate (LF-HC) diet in which the percentage of fat, protein and carbohydrate is 10%, 15% and 75%, respectively.
| Study group | Role | What they receive |
|---|---|---|
| High fat, low carbohydrate diet | Experimental | Not described Receives: Other: High fat, low carbohydrate diet |
| Low fat, high carbohydrate diet | Experimental | Not described Receives: Other: Low fat, high carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose profiling
Real-time blood glucose fluctuations will be recorded by CGM.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start30 Oct 2021
- Primary completion18 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161182
- Sponsor's protocol ID
- 20211011ZJS001
- Status last verified
- Oct 2021
- First submitted
- 18 Nov 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2
- ClinicalTrials.gov ID
- NCT05161182
- Acronym / sponsor ID
- 20211011ZJS001
- Keywords
- Personalized Nutrition, Glucose Metabolism, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 17 Dec 2021 (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.
Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. The experimental diets are isocaloric high fat, low carbohydrate (HF-LC) or low fat, high carbohydrate (LF-HC). With standardized intervention and strictly controlled eating behaviors, the WE-MACNUTR study identifies specific HC-responders and HF-responders in terms of postprandial glucose response.
This is a follow-up study offered to participants who have completed the WE-MACNUTR study in 2019. Volunteers will be asked to participate in four 5-d periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned. Participants will be asked to provide a fasted blood sample and to collect fecal, urine and saliva samples at each visits.
Detailed description
This study is a two arm dietary intervention study. Participants will be recruited from the WE-MACNUTR study based on the defined inclusion and exclusion criteria. The study duration will last up to 21 days.
Volunteers will be asked to participate in four 5-day periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned.
Participants will enter the study on a usual (washout) diet and will have a 5-day run in period for baseline data collection. Participants will be asked to follow dietary guidance and consumed a healthy and balanced diet during this period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat, low carbohydrate diet | Experimental | Other: High fat, low carbohydrate diet |
| Low fat, high carbohydrate diet | Experimental | Other: Low fat, high carbohydrate diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants have completed WE-MACNUTR trial in 2019
- Participants have no traveling plans within 1 months
- Participants are able and willing to comply with the study protocol and provide informed consent
Key exclusion criteria (12 listed)
- Refuse or are unable to provide informed consent to participate in the study
- Have long-term gastrointestinal diseases and take daily relevant medications
- Have taken antibiotics in the last 2 weeks
- Have type 2 diabetes and are taking medications or other treatments
- Have chronic or acute liver disease and are taking medications or other treatments
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 |
|---|---|---|
| High fat, low carbohydrate dietAlso: HF-LCThroughout the 5-day intervention, participants are provided with a high fat, low carbohydrate (HF-LC) diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25%, respectively. | Other | High fat, low carbohydrate diet |
| Low fat, high carbohydrate dietAlso: LF-HCThroughout the 5-day intervention, participants are provided with a low fat, high carbohydrate (LF-HC) diet in which the percentage of fat, protein and carbohydrate is 10%, 15% and 75%, respectively. | Other | Low fat, high carbohydrate diet |
Primary outcome
Blood glucose profiling
Time frame: 20 days
Real-time blood glucose fluctuations will be recorded by CGM.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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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.
Ju-Sheng Zheng, PhD principal investigator
Westlake University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat, low carbohydrate diet and Low fat, high carbohydrate diet in people with Postprandial Hyperglycemia and Metabolic Disorder, Glucose, run by Westlake University 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 1 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood glucose profiling (time frame: 20 days). 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 1 Jun 2022.