Metabolic SyndromeNCT03267901
Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome
A study testing food in people with Metabolic Syndrome, run by ICAN Nutrition Education and Research at 1 site in South Korea.
Trial summary
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2015to 30 Jul 2017
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- the presence of morbid obesity (BMI ≥40)
- the use of any medication for the control of blood pressure, glucose, or lipid metabolism
- a medical history of hypocaloric diet consumption within the past year
- gastrointestinal tract disorders
- post-menopausal women
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
- Conditions
- Metabolic Syndrome
- Being tested
- food
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foodOther
45 g of walnut / iso-caloric white bread
| Study group | Role | What they receive |
|---|---|---|
| Walnut-Control | Experimental | Not described Receives: Other: food |
| Control-Walnut | Experimental | Not described Receives: Other: food |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of waist circumference
Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
Measured: after 16 weeks of daily walnut consumption
changes of blood triglyceride level
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
Measured: after 16 weeks of daily walnut consumption
changes of blood high-density lipoprotein cholesterol levels
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
Measured: after 16 weeks of daily walnut consumption
changes of blood pressure
Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
Measured: after 16 weeks of daily walnut consumption
changes of blood glucose level
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
Measured: after 16 weeks of daily walnut consumption
Secondary outcomes (6)
changes of total cholesterol level
Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
Measured: after 16 weeks of daily walnut consumption
changes of serum apolipoprotein B level
Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
Measured: after 16 weeks of daily walnut consumption
changes of serum adiponectin level
Blood adiponectin (ug/mL) levels were measured using ELISA.
Measured: after 16 weeks of daily walnut consumption
changes of serum leptin level
Blood leptin (ug/mL) levels were measured using ELISA.
Measured: after 16 weeks of daily walnut consumption
changes of serum insulin level
Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
Measured: after 16 weeks of daily walnut consumption
changes of low-density lipoprotein cholesterol level
Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
Measured: after 16 weeks of daily walnut consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 May 2015
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
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 Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICAN Nutrition Education and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Walnut Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267901
- Sponsor's protocol ID
- CWC-2016-MetS
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hwang HJ, Liu Y, Kim HS, Lee H, Lim Y, Park H. Daily walnut intake improves metabolic syndrome status and increases circulating adiponectin levels: randomized controlled crossover trial. Nutr Res Pract. 2019 Apr;13(2):105-114. doi: 10.4162/nrp.2019.13.2.105. Epub 2019 Feb 11.
PubMed 30984354
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
- ClinicalTrials.gov ID
- NCT03267901
- Acronym / sponsor ID
- CWC-2016-MetS
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- ICAN Nutrition Education and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- California Walnut Commission
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 30 Aug 2017 (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.
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut-Control | Experimental | Other: food |
| Control-Walnut | Experimental | Other: food |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- the presence of morbid obesity (BMI ≥40)
- the use of any medication for the control of blood pressure, glucose, or lipid metabolism
- a medical history of hypocaloric diet consumption within the past year
- gastrointestinal tract disorders
- post-menopausal women
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 |
|---|---|---|
| food45 g of walnut / iso-caloric white bread | Other | Control-Walnut, Walnut-Control |
Primary outcome
changes of waist circumference
Time frame: after 16 weeks of daily walnut consumption
Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
changes of blood triglyceride level
Time frame: after 16 weeks of daily walnut consumption
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
changes of blood high-density lipoprotein cholesterol levels
Time frame: after 16 weeks of daily walnut consumption
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
changes of blood pressure
Time frame: after 16 weeks of daily walnut consumption
Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
changes of blood glucose level
Time frame: after 16 weeks of daily walnut consumption
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
6 secondary outcomes
changes of total cholesterol level
Time frame: after 16 weeks of daily walnut consumption
changes of serum apolipoprotein B level
Time frame: after 16 weeks of daily walnut consumption
changes of serum adiponectin level
Time frame: after 16 weeks of daily walnut consumption
changes of serum leptin level
Time frame: after 16 weeks of daily walnut consumption
changes of serum insulin level
Time frame: after 16 weeks of daily walnut consumption
changes of low-density lipoprotein cholesterol level
Time frame: after 16 weeks of daily walnut consumption
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 30 Aug 2017.
- Derived from this study: PubMed 30984354Hwang HJ, Liu Y, Kim HS, Lee H, Lim Y, Park H. Daily walnut intake improves metabolic syndrome status and increases circulating adiponectin levels: randomized controlled crossover trial. Nutr Res Pract. 2019 Apr;13(2):105-114. doi: 10.4162/nrp.2019.13.2.105. Epub 2019 Feb 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food in people with Metabolic Syndrome, run by ICAN Nutrition Education and Research at 1 site in South Korea.
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 0 inclusion and 6 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 30 Aug 2017. 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 South Korea. 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?
changes of waist circumference (time frame: after 16 weeks of daily walnut consumption). The study lists 5 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 NCT03267901, 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 30 Aug 2017.