Diet InterventionNCT03084003
Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials
A study testing Almonds and Graham crackers in people with Diet Intervention, run by University of California, Merced at 1 site in United States.
Trial summary
The purpose of the study is to examine the effects of almond snacking on metabolic, cardiovascular and microbiome profiles in college freshmen. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Intervention
- What is being tested?
- Almonds and Graham crackers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2016to 1 Feb 2019
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-22 years of age
- Newly enrolled, 1st-year college students at University of California, Merced
- Willing to eat almonds and study snacks
- Willing to comply with the study protocol
- Consistent diet and activity patterns
- Non-smoker >1 year or more
Who cannot join
- Nut allergies
- Illicit drug use
- Medications that affect metabolism or appetite
- Anti-inflammatory medications, analgesics and antibiotics
- Diabetes or pre-diabetes, uncontrolled hypertension, cardiovascular disease or dyslipidemia requiring drug therapy
- Gastrointestinal disease and/or bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Merced
Merced, California, 95343
About this study
Official title: Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials: Implications of Systemic Glucoregulatory Mechanisms
The purpose of the study is to examine the effects of almond snacking on metabolic, cardiovascular and microbiome profiles in college freshmen.
Read the detailed description
Nut (principally almond) consumption helps ameliorate cardiovascular disease, reduce the risk of type II diabetes mellitus (T2DM). Recent studies have demonstrated improvements in glycemic control in T2DM and impaired glucose tolerant (IGT) subjects as well as in healthy adults. The association between nut consumption and diabetes prevalence is largely mediated by changes in body mass (adiposity). The application of metabolomic and lipidomic approaches to better asses the mechanisms regulating carbohydrates and lipids in an almond-based study has not been performed.
Additionally, the gut microbiota has been proposed to contribute to a number of metabolic disorders including insulin sensitivity, glucose metabolism, and other cardiometabolic risk factors. However, data demonstrating the complex interactions among dietary interventions, gut microbiome, glucose regulation, and cardiovascular phenotype are lacking.
Furthermore, because all the studies on nut consumption and health have been performed on adults (median age of subjects: +40 years) and given the increasing incidence of metabolic disorders (obesity, insulin resistance, etc.) at much younger stages of life especially in the Central Valley of California, no data exist on the potential benefits of almonds in ameliorating metabolic disorders at a much earlier life stage. This may be clinically more important than studies in adults because the transition from adolescence to adulthood is associated with a number of potential risk factors unique to this age group, especially in those that enter their first year of college. The fixed age of the participants contributes to a more homogeneous population than has been previously studied, which greatly minimizes the potential for age-dependent alterations in physiology to either potentiate or mask the effects of the almonds on metabolic mechanisms. The nutritional independence that is associated with going away to college poses many potential health challenges, for example the phenomenon, "Freshman 15". The increased prevalence of overweight and obesity is greatest in 18-29 year olds, especially among those reporting some college education (10.6%-17.8% vs 7.1%-12.1% in 18-29 year olds overall) suggesting that some aspect of the collegiate experience is associated with weight gain.
While almond-supplemented diets have been shown to reduce body mass or ameliorate weight gain, the evidence substantiating the benefits of functional foods in addressing the weight gain commonly associated with the transition to college is scarce and an untapped area of research. Furthermore, this transition to nutritional independence makes new college students vulnerable to additional alterations in eating patterns. Among these concerns are the relatively high number of college freshmen that reported skipping breakfast (20%-43%), which is by far the most skipped meal among those studies reviewed. This is important because chronically skipping breakfast in adolescents has detrimental outcomes on cardiometabolic health and has negative impacts on academic performance. Additionally, most college students snack, with snacking common both in the morning and the afternoon. Data suggest a benefit to snacking on peanuts and almonds. However, the benefits of snacking in young college students who routinely skip a meal (breakfast here) are not defined. Therefore, being able to demonstrate the benefits of almonds in college "breakfast skippers" would have significant implications for young adults in their first year of college, and thus, provide an ideal opportunity to further address this line of inquiry. Lastly, the application of metabolomic and lipidomic approaches to better assess the mechanisms regulating carbohydrates and lipids in an almond-based study has not been performed. Advancements in high-throughput analytical techniques have initiated a renaissance in the study of metabolism on a grand scale that allow for robust assessment of nutritional status and cellular responses. These approaches provide an advantage of mapping metabolites in such a fashion that changes in mechanisms can be elucidated as demonstrated by the SuGAR Project.
- Conditions
- Diet Intervention
- Being tested
- Almonds, Graham crackers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
Graham crackersDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Almond group | Experimental | 2 oz. of almonds everyday for 8 weeks Receives: Dietary Supplement: Almonds |
| Control group | Active comparator | Isoenergetic control group 5 graham cracker sheets everyday for 8 weeks Receives: Dietary Supplement: Graham crackers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose
Measured: Change from baseline at 8 weeks
2-hour oral glucose tolerance test
Measured: At the end of 8 week intervention
Change in fasting blood insulin
Measured: Change from baseline at 8 weeks
Change in stool microbiome profiles
Measured: Change from baseline at 8 weeks
Secondary outcomes (14)
Weight
Measured: Every 2 weeks over the 8 week intervention
Body composition
Measured: Every 2 weeks over the 8 week intervention
Waist circumference
Measured: Every 2 weeks over the 8 week intervention
Blood pressure
Measured: Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Measured: Baseline, 4 weeks into intervention and end of 8 week intervention
Hip circumference
Measured: Every 2 weeks over the 8 week intervention
Flow Mediated Dilation (FMD)
As a measure of endothelial function
Measured: At the end of 8 week intervention
Urinary 8-isoprostane
Measured: Baseline and end of 8 week intervention
Urinary electrolytes
Measured: Baseline and end of 8 week intervention
Urinary angiotensinogen
Measured: Baseline and end of 8 week intervention
Urinary creatinine clearance
Measured: Baseline and end of 8 week intervention
Fasting lipid profile
Measured: Baseline, 4 weeks into intervention and end of 8 week intervention
Physical activity
Research Tracker 6 (RT6) accelerometers
Measured: Baseline, 4 weeks into intervention and end of 8 week intervention
Hepatic glucose metabolism
Isotopic dilution
Measured: End of 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start18 Feb 2016
- Primary completion1 May 2017
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Diet InterventionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Merced
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudy Ortiz, University of California, Merced
- Investigators
- Rudy Ortiz, PhD, Principal investigator, UNIV OF CALIFORNIA MERCED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084003
- Sponsor's protocol ID
- UCM2016-86
- Status last verified
- May 2021
- First submitted
- 21 Feb 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abazarfard Z, Salehi M, Keshavarzi S. The effect of almonds on anthropometric measurements and lipid profile in overweight and obese females in a weight reduction program: A randomized controlled clinical trial. J Res Med Sci. 2014 May;19(5):457-64.
PubMed 25097630Adams SH, Hoppel CL, Lok KH, Zhao L, Wong SW, Minkler PE, Hwang DH, Newman JW, Garvey WT. Plasma acylcarnitine profiles suggest incomplete long-chain fatty acid beta-oxidation and altered tricarboxylic acid cycle activity in type 2 diabetic African-American women. J Nutr. 2009 Jun;139(6):1073-81. doi: 10.3945/jn.108.103754. Epub 2009 Apr 15.
PubMed 19369366Berkey CS, Rockett HR, Gillman MW, Field AE, Colditz GA. Longitudinal study of skipping breakfast and weight change in adolescents. Int J Obes Relat Metab Disord. 2003 Oct;27(10):1258-66. doi: 10.1038/sj.ijo.0802402.
PubMed 14513075Brevard PB, Ricketts CD. Residence of college students affects dietary intake, physical activity, and serum lipid levels. J Am Diet Assoc. 1996 Jan;96(1):35-8. doi: 10.1016/S0002-8223(96)00011-9.
PubMed 8537567Cani PD, Delzenne NM. Gut microflora as a target for energy and metabolic homeostasis. Curr Opin Clin Nutr Metab Care. 2007 Nov;10(6):729-34. doi: 10.1097/MCO.0b013e3282efdebb.
PubMed 18089955Cohen AE, Johnston CS. Almond ingestion at mealtime reduces postprandial glycemia and chronic ingestion reduces hemoglobin A(1c) in individuals with well-controlled type 2 diabetes mellitus. Metabolism. 2011 Sep;60(9):1312-7. doi: 10.1016/j.metabol.2011.01.017. Epub 2011 Apr 12.
PubMed 21489570Devitt AA, Kuevi A, Coelho SB, Lartey A, Lokko P, Costa N, Bressan J, Mattes RD. Appetitive and Dietary Effects of Consuming an Energy-Dense Food (Peanuts) with or between Meals by Snackers and Nonsnackers. J Nutr Metab. 2011;2011:928352. doi: 10.1155/2011/928352. Epub 2011 Jan 22.
PubMed 21808728Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes? Obes Rev. 2011 Apr;12(4):272-81. doi: 10.1111/j.1467-789X.2010.00797.x. Epub 2010 Aug 26.
PubMed 20804522Driskell JA, Kim YN, Goebel KJ. Few differences found in the typical eating and physical activity habits of lower-level and upper-level university students. J Am Diet Assoc. 2005 May;105(5):798-801. doi: 10.1016/j.jada.2005.02.004.
PubMed 15883559Fiehn O, Garvey WT, Newman JW, Lok KH, Hoppel CL, Adams SH. Plasma metabolomic profiles reflective of glucose homeostasis in non-diabetic and type 2 diabetic obese African-American women. PLoS One. 2010 Dec 10;5(12):e15234. doi: 10.1371/journal.pone.0015234.
PubMed 21170321Grapov D, Adams SH, Pedersen TL, Garvey WT, Newman JW. Type 2 diabetes associated changes in the plasma non-esterified fatty acids, oxylipins and endocannabinoids. PLoS One. 2012;7(11):e48852. doi: 10.1371/journal.pone.0048852. Epub 2012 Nov 8.
PubMed 23144998Heatherton TF, Nichols P, Mahamedi F, Keel P. Body weight, dieting, and eating disorder symptoms among college students, 1982 to 1992. Am J Psychiatry. 1995 Nov;152(11):1623-9. doi: 10.1176/ajp.152.11.1623.
PubMed 7485625Hoffman DJ, Policastro P, Quick V, Lee SK. Changes in body weight and fat mass of men and women in the first year of college: A study of the "freshman 15". J Am Coll Health. 2006 Jul-Aug;55(1):41-5. doi: 10.3200/JACH.55.1.41-46.
PubMed 16889314Josse AR, Kendall CW, Augustin LS, Ellis PR, Jenkins DJ. Almonds and postprandial glycemia--a dose-response study. Metabolism. 2007 Mar;56(3):400-4. doi: 10.1016/j.metabol.2006.10.024.
PubMed 17292730Li SC, Liu YH, Liu JF, Chang WH, Chen CM, Chen CY. Almond consumption improved glycemic control and lipid profiles in patients with type 2 diabetes mellitus. Metabolism. 2011 Apr;60(4):474-9. doi: 10.1016/j.metabol.2010.04.009. Epub 2010 May 23.
PubMed 20580779
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials: Implications of Systemic Glucoregulatory Mechanisms
- ClinicalTrials.gov ID
- NCT03084003
- Acronym / sponsor ID
- UCM2016-86
- Conditions
- Diet Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 20 Mar 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.
The purpose of the study is to examine the effects of almond snacking on metabolic, cardiovascular and microbiome profiles in college freshmen.
Detailed description
Nut (principally almond) consumption helps ameliorate cardiovascular disease, reduce the risk of type II diabetes mellitus (T2DM). Recent studies have demonstrated improvements in glycemic control in T2DM and impaired glucose tolerant (IGT) subjects as well as in healthy adults. The association between nut consumption and diabetes prevalence is largely mediated by changes in body mass (adiposity). The application of metabolomic and lipidomic approaches to better asses the mechanisms regulating carbohydrates and lipids in an almond-based study has not been performed.
Additionally, the gut microbiota has been proposed to contribute to a number of metabolic disorders including insulin sensitivity, glucose metabolism, and other cardiometabolic risk factors. However, data demonstrating the complex interactions among dietary interventions, gut microbiome, glucose regulation, and cardiovascular phenotype are lacking.
Furthermore, because all the studies on nut consumption and health have been performed on adults (median age of subjects: +40 years) and given the increasing incidence of metabolic disorders (obesity, insulin resistance, etc.) at much younger stages of life especially in the Central Valley of California, no data exist on the potential benefits of almonds in ameliorating metabolic disorders at a much earlier life stage. This may be clinically more important than studies in adults because the transition from adolescence to adulthood is associated with a number of potential risk factors unique to this age group, especially in those that enter their first year of college. The fixed age of the participants contributes to a more homogeneous population than has been previously studied, which greatly minimizes the potential for age-dependent alterations in physiology to either potentiate or mask the effects of the almonds on metabolic mechanisms. The nutritional independence that is associated with going away to college poses many potential health challenges, for example the phenomenon, "Freshman 15". The increased prevalence of overweight and obesity is greatest in 18-29 year olds, especially among those reporting some college education (10.6%-17.8% vs 7.1%-12.1% in 18-29 year olds overall) suggesting that some aspect of the collegiate experience is associated with weight gain.
While almond-supplemented diets have been shown to reduce body mass or ameliorate weight gain, the evidence substantiating the benefits of functional foods in addressing the weight gain commonly associated with the transition to college is scarce and an untapped area of research. Furthermore, this transition to nutritional independence makes new college students vulnerable to additional alterations in eating patterns. Among these concerns are the relatively high number of college freshmen that reported skipping breakfast (20%-43%), which is by far the most skipped meal among those studies reviewed. This is important because chronically skipping breakfast in adolescents has detrimental outcomes on cardiometabolic health and has negative impacts on academic performance. Additionally, most college students snack, with snacking common both in the morning and the afternoon. Data suggest a benefit to snacking on peanuts and almonds. However, the benefits of snacking in young college students who routinely skip a meal (breakfast here) are not defined. Therefore, being able to demonstrate the benefits of almonds in college "breakfast skippers" would have significant implications for young adults in their first year of college, and thus, provide an ideal opportunity to further address this line of inquiry. Lastly, the application of metabolomic and lipidomic approaches to better assess the mechanisms regulating carbohydrates and lipids in an almond-based study has not been performed. Advancements in high-throughput analytical techniques have initiated a renaissance in the study of metabolism on a grand scale that allow for robust assessment of nutritional status and cellular responses. These approaches provide an advantage of mapping metabolites in such a fashion that changes in mechanisms can be elucidated as demonstrated by the SuGAR Project.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond group | Experimental | Dietary Supplement: Almonds2 oz. of almonds everyday for 8 weeks |
| Control group | Active comparator | Dietary Supplement: Graham crackersIsoenergetic control group 5 graham cracker sheets everyday for 8 weeks |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Almonds | Dietary supplement | Almond group |
| Graham crackers | Dietary supplement | Control group |
Primary outcome
Change in fasting blood glucose
Time frame: Change from baseline at 8 weeks
2-hour oral glucose tolerance test
Time frame: At the end of 8 week intervention
Change in fasting blood insulin
Time frame: Change from baseline at 8 weeks
Change in stool microbiome profiles
Time frame: Change from baseline at 8 weeks
14 secondary outcomes
Weight
Time frame: Every 2 weeks over the 8 week intervention
Body composition
Time frame: Every 2 weeks over the 8 week intervention
Waist circumference
Time frame: Every 2 weeks over the 8 week intervention
Blood pressure
Time frame: Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Time frame: Baseline, 4 weeks into intervention and end of 8 week intervention
Hip circumference
Time frame: Every 2 weeks over the 8 week intervention
Flow Mediated Dilation (FMD)
Time frame: At the end of 8 week intervention
Urinary 8-isoprostane
Time frame: Baseline and end of 8 week intervention
Urinary electrolytes
Time frame: Baseline and end of 8 week intervention
Urinary angiotensinogen
Time frame: Baseline and end of 8 week intervention
Urinary creatinine clearance
Time frame: Baseline and end of 8 week intervention
Fasting lipid profile
Time frame: Baseline, 4 weeks into intervention and end of 8 week intervention
Physical activity
Time frame: Baseline, 4 weeks into intervention and end of 8 week intervention
Hepatic glucose metabolism
Time frame: End of 8 week intervention
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 May 2021.
- Background: PubMed 25097630Abazarfard Z, Salehi M, Keshavarzi S. The effect of almonds on anthropometric measurements and lipid profile in overweight and obese females in a weight reduction program: A randomized controlled clinical trial. J Res Med Sci. 2014 May;19(5):457-64.
- Background: PubMed 19369366Adams SH, Hoppel CL, Lok KH, Zhao L, Wong SW, Minkler PE, Hwang DH, Newman JW, Garvey WT. Plasma acylcarnitine profiles suggest incomplete long-chain fatty acid beta-oxidation and altered tricarboxylic acid cycle activity in type 2 diabetic African-American women. J Nutr. 2009 Jun;139(6):1073-81. doi: 10.3945/jn.108.103754. Epub 2009 Apr 15.
- Background: PubMed 14513075Berkey CS, Rockett HR, Gillman MW, Field AE, Colditz GA. Longitudinal study of skipping breakfast and weight change in adolescents. Int J Obes Relat Metab Disord. 2003 Oct;27(10):1258-66. doi: 10.1038/sj.ijo.0802402.
- Background: PubMed 8537567Brevard PB, Ricketts CD. Residence of college students affects dietary intake, physical activity, and serum lipid levels. J Am Diet Assoc. 1996 Jan;96(1):35-8. doi: 10.1016/S0002-8223(96)00011-9.
- Background: PubMed 18089955Cani PD, Delzenne NM. Gut microflora as a target for energy and metabolic homeostasis. Curr Opin Clin Nutr Metab Care. 2007 Nov;10(6):729-34. doi: 10.1097/MCO.0b013e3282efdebb.
- Background: PubMed 21489570Cohen AE, Johnston CS. Almond ingestion at mealtime reduces postprandial glycemia and chronic ingestion reduces hemoglobin A(1c) in individuals with well-controlled type 2 diabetes mellitus. Metabolism. 2011 Sep;60(9):1312-7. doi: 10.1016/j.metabol.2011.01.017. Epub 2011 Apr 12.
- Background: PubMed 21808728Devitt AA, Kuevi A, Coelho SB, Lartey A, Lokko P, Costa N, Bressan J, Mattes RD. Appetitive and Dietary Effects of Consuming an Energy-Dense Food (Peanuts) with or between Meals by Snackers and Nonsnackers. J Nutr Metab. 2011;2011:928352. doi: 10.1155/2011/928352. Epub 2011 Jan 22.
- Background: PubMed 20804522Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes? Obes Rev. 2011 Apr;12(4):272-81. doi: 10.1111/j.1467-789X.2010.00797.x. Epub 2010 Aug 26.
- Background: PubMed 15883559Driskell JA, Kim YN, Goebel KJ. Few differences found in the typical eating and physical activity habits of lower-level and upper-level university students. J Am Diet Assoc. 2005 May;105(5):798-801. doi: 10.1016/j.jada.2005.02.004.
- Background: PubMed 21170321Fiehn O, Garvey WT, Newman JW, Lok KH, Hoppel CL, Adams SH. Plasma metabolomic profiles reflective of glucose homeostasis in non-diabetic and type 2 diabetic obese African-American women. PLoS One. 2010 Dec 10;5(12):e15234. doi: 10.1371/journal.pone.0015234.
- Background: PubMed 23144998Grapov D, Adams SH, Pedersen TL, Garvey WT, Newman JW. Type 2 diabetes associated changes in the plasma non-esterified fatty acids, oxylipins and endocannabinoids. PLoS One. 2012;7(11):e48852. doi: 10.1371/journal.pone.0048852. Epub 2012 Nov 8.
- Background: PubMed 7485625Heatherton TF, Nichols P, Mahamedi F, Keel P. Body weight, dieting, and eating disorder symptoms among college students, 1982 to 1992. Am J Psychiatry. 1995 Nov;152(11):1623-9. doi: 10.1176/ajp.152.11.1623.
- Nuts for diabetes prevention and managementLink provided by the sponsor.
- Reduced physical activity levels associated with obesity in rural Hispanic adolescent females.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diet Intervention
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
Rudy Ortiz, PhD principal investigator
UNIV OF CALIFORNIA MERCED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds and Graham crackers in people with Diet Intervention, run by University of California, Merced 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 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 7 May 2021. 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 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?
Change in fasting blood glucose (time frame: Change from baseline at 8 weeks). The study lists 4 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 NCT03084003, which also lists 29 linked publications.
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 May 2021.