An interventional study of Almond and Control in Glucose Intolerance and Glucose Metabolism Disorders (Including Diabetes Mellitus), sponsored by Purdue University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Purdue University · Not applicable, Interventional, and Basic science
This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.
Globally, it is projected that 418 million people will have impaired glucose tolerance by 2025. In the US, an estimated 34 million Americans have diabetes and 88 million, 33% of adults, have pre-diabetes. Impaired glucose tolerance is now manifesting in young adults where 20% of those 12-18 years of age have prediabetes. The current prevalence of Type 2 diabetes is over 8%, but it is projected that up to a third of Americans will develop diabetes in their lifetime. Additionally, the total annual cost of diabetes is approximately $327 which accounts for 25% of all US health care costs. Moreover, the costs rose 60% from 2007 to 2017 and this trend is continuing.
Diet is the preferred approach for management for this diet-related chronic disorder. Accumulating evidence suggests almond consumption decreases postprandial glycemia and may evoke a second meal effect, especially when they are consumed at breakfast or as an afternoon snack, which may aid in long-term glycemic control. Additionally, almond consumption can decrease total and LDL cholesterol, resulting in lower peripheral insulin resistance and cardiometabolic complications from type 2 diabetes mellitus. However, there is mixed evidence on the effects of almond consumption on HbA1c, a clinically important endpoint that provides a reliable measure of long-term glycemia and is correlated with risk of complications from diabetes. Thus, the investigators hypothesize a beneficial effect of regular almond consumption on long-term glycemic control in individuals with elevated baseline HbA1c.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's planned enrollment of 84 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →Purdue University is the lead sponsor of 168 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.
Other: Almond
Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.
Other: Control
Participants will consume almonds every day for 16 weeks.
Participants will consume pretzels every day for 16 weeks.
HbA1c
Time frame: Baseline
Change in HbA1c
HbA1c % change
Time frame: 16 weeks
Glucose response to a meal tolerance test
mg/dl
Time frame: Baseline and week 16
Insulin response to a meal tolerance test
mmol/L
Time frame: Baseline and week 16
Chronic glycemia
mg/dl
Time frame: Baseline, week 8 and week 16
Food intake
kcal
Time frame: Two days (one week day and one weekend day) at screening, week 8 and week 16.
Body weight
Kilograms (kg)
Time frame: Screening, baseline, week 4, week 8, week 12, and week 16
Body composition
Percentage (%)
Time frame: Baseline, week 16
Hedonic survey
mm on a VAS
Time frame: Baseline, week 4, week 8, week 12. week 16
Compliance - Vitamin E
mg/L
Time frame: Baseline, week 8 and week 16.
Compliance - fatty acid profile
% fatty acid composition
Time frame: Baseline, week 8 and week 16
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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