Type-2 DiabetesNCT01787214
Walnuts and Glucose Variability
A study testing Full dose and Half dose in people with Type-2 Diabetes, run by Loma Linda University at 1 site in United States.
Trial summary
Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type-2 Diabetes
- What is being tested?
- Full dose and Half dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2013
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults between age 40 and 70 years with type 2 diabetes
- duration of type 2 diabetes more than 6 months but less than 10 years
- HbA1c 6.0-8.0%
- BMI 25-40 kg/m2
- diet controlled or stable dose of metformin for at least 3 months
- willing to test blood glucose with personal meter twice a day during study test days
Who cannot join
- using oral hypoglycemic agents or insulin
- history of ischemic heart disease or congestive heart failure
- history of severe diabetic complication (neuropathy, renal failure, stroke)
- taking medication affecting glucose levels (i.e. corticosteroids)
- active infectious disease
- active malignancy
Show all 11Show fewer
- pregnant or breast feeding woman
- smoker
- history of daily caffeine or alcohol intake
- known allergy to nuts
- lactose or gluten intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University, Nichol Hall
Loma Linda, California, 92350
About this study
Official title: The Effect of Walnuts on Glucose Variability in Adults With Type-2 Diabetes Mellitus: a Dose-response Metabolic Feeding Study
Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM will participate in the study. Subjects will be randomized to consume an ADA diet with or without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar twice daily and wear a continuous glucose monitor during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and will be recruited from the surrounding community using flyers and public service announcements. Consent will take place in the Department of Nutrition at Loma Linda University by the study investigators. In total, subject participation will last 5 weeks and all meals will be provided during the 3 study periods.
- Conditions
- Type-2 Diabetes
- Being tested
- Full dose, Half dose, Control
- Keywords
- glucose variability, glycemia, type-2 diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full doseDietary supplement
20% of daily energy needs supplied by walnuts
Half doseDietary supplement
10% of daily energy needs supplied by walnuts
ControlDietary supplement
Walnut free meals
| Study group | Role | What they receive |
|---|---|---|
| Full dose | Active comparator | full dose of walnuts (20% energy needs) Receives: Dietary Supplement: Full dose |
| Half-dose | Active comparator | Half dose of walnuts (10% of energy needs) Receives: Dietary Supplement: Half dose |
| Control | Other | Walnut free meals Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-day glucose variability
The primary objective is to evaluate the effect of two isocaloric walnut-enriched meal plans versus a walnut-free ADA meal plan on within-day glucose variability in adults with diabetes by assessing: a) the overall standard deviation (SD) around the sensor glucose calculated for each day and then averaged over the 3-day study periods; b) the mean amplitude of glycemic excursions (MAGE) over the 3-day study periods.
Measured: 3 days
Secondary outcomes (8)
Glucose variability dose response
A secondary objective will be to test for a dose-response effect, i.e. the more walnuts (full-dose versus half-dose) the lower the glucose variability.
Measured: 3 days
Dose response to between-day glycemic variability
The effect of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free) on the mean of the daily differences(MODD) will be recorded as a measure of between-day glycemic variability
Measured: 3 days
Glucose levels by meal
Glucose levels will be measured before and after breakfast, lunch and dinner for each of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free)
Measured: 3 days
Mean glucose of sensor range
The mean of the glucose for the range captured on each sensor (sensor maximal glucose level minus minimal glucose level will be recorded
Measured: 3 days
Duration of hypoglycemia
The duration of hypoglycemia will be measured as hours per day for each of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free)
Measured: 3 days
Duration of hyperglycemia
The duration of hyperglycemia will be measured as hours per day for each of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free)
Measured: 3 days
Net glycemia at 2 hours
The continuous overall net glycemic action will be measured at 2 hour intervals
Measured: 3 days
Net glycemia at 4 hours
The continuous overall net glycemic action will be measured at 4 hour intervals
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 DiabetesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Principal investigator, Michelle Wien, Loma Linda University
- Investigators
- Michelle Wien, DrPH, RD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787214
- Sponsor's protocol ID
- walnuts and glucose
- Status last verified
- Mar 2014
- First submitted
- 1 Feb 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Walnuts on Glucose Variability in Adults With Type-2 Diabetes Mellitus: a Dose-response Metabolic Feeding Study
- ClinicalTrials.gov ID
- NCT01787214
- Acronym / sponsor ID
- walnuts and glucose
- Conditions
- Type-2 Diabetes
- Keywords
- glucose variability, glycemia, type-2 diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Feb 2013 (estimated)
- 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.
Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM will participate in the study. Subjects will be randomized to consume an ADA diet with or without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar twice daily and wear a continuous glucose monitor during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and will be recruited from the surrounding community using flyers and public service announcements. Consent will take place in the Department of Nutrition at Loma Linda University by the study investigators. In total, subject participation will last 5 weeks and all meals will be provided during the 3 study periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full dose | Active comparator | Dietary Supplement: Full dosefull dose of walnuts (20% energy needs) |
| Half-dose | Active comparator | Dietary Supplement: Half doseHalf dose of walnuts (10% of energy needs) |
| Control | Other | Dietary Supplement: ControlWalnut free meals |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults between age 40 and 70 years with type 2 diabetes
- duration of type 2 diabetes more than 6 months but less than 10 years
- HbA1c 6.0-8.0%
- BMI 25-40 kg/m2
- diet controlled or stable dose of metformin for at least 3 months
Key exclusion criteria (11 listed)
- using oral hypoglycemic agents or insulin
- history of ischemic heart disease or congestive heart failure
- history of severe diabetic complication (neuropathy, renal failure, stroke)
- taking medication affecting glucose levels (i.e. corticosteroids)
- active infectious disease
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 |
|---|---|---|
| Full dose20% of daily energy needs supplied by walnuts | Dietary supplement | Full dose |
| Half dose10% of daily energy needs supplied by walnuts | Dietary supplement | Half-dose |
| ControlWalnut free meals | Dietary supplement | Control |
Primary outcome
Within-day glucose variability
Time frame: 3 days
The primary objective is to evaluate the effect of two isocaloric walnut-enriched meal plans versus a walnut-free ADA meal plan on within-day glucose variability in adults with diabetes by assessing: a) the overall standard deviation (SD) around the sensor glucose calculated for each day and then averaged over the 3-day study periods; b) the mean amplitude of glycemic excursions (MAGE) over the 3-day study periods.
8 secondary outcomes
Glucose variability dose response
Time frame: 3 days
Dose response to between-day glycemic variability
Time frame: 3 days
Glucose levels by meal
Time frame: 3 days
Mean glucose of sensor range
Time frame: 3 days
Duration of hypoglycemia
Time frame: 3 days
Duration of hyperglycemia
Time frame: 3 days
Net glycemia at 2 hours
Time frame: 3 days
Net glycemia at 4 hours
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
Michelle Wien, DrPH, RD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full dose and Half dose in people with Type-2 Diabetes, run by Loma Linda University at 1 site in United States.
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 11 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: stopped early, as of the sponsor's last update on 18 Mar 2014. 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 United States. 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 was stopped early (reason given: Funding withdrawn). 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?
Within-day glucose variability (time frame: 3 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 18 Mar 2014.