Almond Consumption and Glycemia
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|ClinicalTrials.gov Identifier: NCT03236116|
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glucose Intolerance Appetite Disorders Glucose Metabolism Disorders (Including Diabetes Mellitus) Lipid Metabolism Disorder||Other: Almonds Other: Control (no nuts)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Almond Consumption and Glycemia|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: Almond Group
Participants will consumed almonds every day for 6 months.
Participants will consume almonds everyday for 6 months.
Experimental: Control Group
Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nut products.
Other: Control (no nuts)
Participants will not be permited to consume any nuts for 6 months.
- 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
- Diet Quality [ Time Frame: Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6. ]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.
- Compliance [ Time Frame: Baseline, month 2, 4, and 6. ]Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236116
|Contact: Richard D Mattes, PhDfirstname.lastname@example.org|
|Contact: Stephanie R Hunteremail@example.com|
|United States, Indiana|
|West Lafayette, Indiana, United States, 47907|
|Contact: Richard D Mattes, PhD, RD, MPH 765-494-0662 firstname.lastname@example.org|
|Principal Investigator: Richard D Mattes, PhD, RD, MPH|
|West Lafayette, Indiana, United States, 47909|
|Contact: Richard D Mattes, Phd 765-494-0662 email@example.com|
|Contact: Stephanie R Hunter 765-496-3607 firstname.lastname@example.org|
|Principal Investigator:||Richard D Mattes, PhD||Purdue University|