Glucose IntoleranceNCT03236116
Almond Consumption and Glycemia
A study testing Almonds in people with Glucose Intolerance and Appetite Disorders, run by Purdue University at 3 sites in United States.
Trial summary
This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Appetite Disorders, Glucose Metabolism Disorders (Including Diabetes Mellitus)
- What is being tested?
- Almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2017to 31 Dec 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meeting one of the following body fat distribution criteria determined by DEXA: 1. High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat
- 18-60 years
- no nut allergies
Who cannot join
- Not meeting one of the body fat distribution criteria
- allergic to nuts
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Purdue University
West Lafayette, Indiana, 47907
Purdue University
West Lafayette, Indiana, 47909
About this study
This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.
Read the detailed description
There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots.
Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.
- Conditions
- Glucose Intolerance, Appetite Disorders, Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorder
- Being tested
- Almonds, Control (no nuts)
- Medical subject headings
- Glucose Intolerance, Feeding and Eating Disorders, Glucose Metabolism Disorders, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsOther
Participants will consume almonds everyday for 6 months.
Control (no nuts)Other
Participants will not be permited to consume any nuts for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Almond Group | Experimental | Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products. Receives: Other: Almonds |
| Control Group | Experimental | Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products. Receives: Other: Control (no nuts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c.
Measured: Baseline
fasting glucose
fasting glucose,
Measured: Baseline
fasting triglycerides
fasting triglycerides
Measured: Baseline
Change in Body weight
Body weight
Measured: Every two weeks for 6 months.
Body composition
Body composition
Measured: Baseline
GLP-1
GLP-1
Measured: Baseline
Change in HbA1c
HbA1c.
Measured: 6 months
Change in fasting glucose
fasting glucose
Measured: 6 months
fasting triglycerides
fasting triglycerides
Measured: 6 months
Change in Body composition
Body composition
Measured: 6 months
Change in GLP-1
GLP-1
Measured: 6 months
fasting insulin
fasting insulin
Measured: Baseline
total cholesterol
total cholesterol
Measured: Baseline
LDL-cholesterol
LDL-cholesterol
Measured: Baseline
HDL-cholesterol
HDL-cholesterol
Measured: Baseline
GIP
GIP
Measured: Baseline
change in fasting insulin
fasting insulin
Measured: 6 months
change in total cholesterol
total cholesterol
Measured: 6 months
change in LDL-cholesterol
LDL-cholesterol
Measured: 6 months
change in HDL-cholesterol
HDL-cholesterol
Measured: 6 months
change in GIP
GIP
Measured: 6 months
C-peptide
Measured: baseline
C-peptide
Measured: 6 months
Homa-IR
Measured: baseline
Homa-IR
Measured: 6 months
Homa-Percent Beta
Measured: Baseline
Homa-Percent Beta
Measured: 6 months
Secondary outcomes (2)
Diet Quality
Determine the effect of substituting a wholesome snack food (almonds) for more traditional, less nutrient dense, snack foods on total diet quality. Food intake will be measured by the ASA-24 for three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Measured: Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Compliance
Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.
Measured: Baseline, month 2, 4, and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Aug 2017
- Primary completion20 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236116
- Sponsor's protocol ID
- 055-047
- Status last verified
- Jan 2021
- First submitted
- 13 Jul 2017
- Last updated
- 7 Jan 2021
- 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 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almond Consumption and Glycemia
- ClinicalTrials.gov ID
- NCT03236116
- Acronym / sponsor ID
- 055-047
- Conditions
- Glucose Intolerance, Appetite Disorders, Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 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.
This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.
Detailed description
There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots.
Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond Group | Experimental | Other: AlmondsParticipants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products. |
| Control Group | Experimental | Other: Control (no nuts)Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meeting one of the following body fat distribution criteria determined by DEXA: 1. High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat
- 18-60 years
- no nut allergies
Key exclusion criteria (2 listed)
- Not meeting one of the body fat distribution criteria
- allergic to nuts
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 |
|---|---|---|
| AlmondsParticipants will consume almonds everyday for 6 months. | Other | Almond Group |
| Control (no nuts)Participants will not be permited to consume any nuts for 6 months. | Other | Control Group |
Primary outcome
HbA1c
Time frame: Baseline
HbA1c.
fasting glucose
Time frame: Baseline
fasting glucose,
fasting triglycerides
Time frame: Baseline
fasting triglycerides
Change in Body weight
Time frame: Every two weeks for 6 months.
Body weight
Body composition
Time frame: Baseline
Body composition
GLP-1
Time frame: Baseline
GLP-1
Change in HbA1c
Time frame: 6 months
HbA1c.
Change in fasting glucose
Time frame: 6 months
fasting glucose
fasting triglycerides
Time frame: 6 months
fasting triglycerides
Change in Body composition
Time frame: 6 months
Body composition
Change in GLP-1
Time frame: 6 months
GLP-1
fasting insulin
Time frame: Baseline
fasting insulin
total cholesterol
Time frame: Baseline
total cholesterol
LDL-cholesterol
Time frame: Baseline
LDL-cholesterol
HDL-cholesterol
Time frame: Baseline
HDL-cholesterol
GIP
Time frame: Baseline
GIP
change in fasting insulin
Time frame: 6 months
fasting insulin
change in total cholesterol
Time frame: 6 months
total cholesterol
change in LDL-cholesterol
Time frame: 6 months
LDL-cholesterol
change in HDL-cholesterol
Time frame: 6 months
HDL-cholesterol
change in GIP
Time frame: 6 months
GIP
C-peptide
Time frame: baseline
C-peptide
Time frame: 6 months
Homa-IR
Time frame: baseline
Homa-IR
Time frame: 6 months
Homa-Percent Beta
Time frame: Baseline
Homa-Percent Beta
Time frame: 6 months
2 secondary outcomes
Diet Quality
Time frame: Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Compliance
Time frame: Baseline, month 2, 4, and 6.
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 7 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Richard D Mattes, PhD principal investigator
Purdue University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds in people with Glucose Intolerance and Appetite Disorders, run by Purdue University at 3 sites 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 3 inclusion and 2 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
HbA1c (time frame: Baseline). The study lists 27 primary outcomes in all. 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 7 Jan 2021.