Almond Consumption and Glycemia
Primary Purpose
Glucose Intolerance, Appetite Disorders, Glucose Metabolism Disorders (Including Diabetes Mellitus)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almonds
Control (no nuts)
Sponsored by
About this trial
This is an interventional basic science trial for Glucose Intolerance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting one of the body fat distribution criteria
- allergic to nuts
Sites / Locations
- Indiana University School of Medicine
- Purdue University
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Almond Group
Control Group
Arm Description
Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.
Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products.
Outcomes
Primary Outcome Measures
HbA1c
HbA1c.
fasting glucose
fasting glucose,
fasting triglycerides
fasting triglycerides
Change in Body weight
Body weight
Body composition
Body composition
GLP-1
GLP-1
Change in HbA1c
HbA1c.
Change in fasting glucose
fasting glucose
fasting triglycerides
fasting triglycerides
Change in Body composition
Body composition
Change in GLP-1
GLP-1
fasting insulin
fasting insulin
total cholesterol
total cholesterol
LDL-cholesterol
LDL-cholesterol
HDL-cholesterol
HDL-cholesterol
GIP
GIP
change in fasting insulin
fasting insulin
change in total cholesterol
total cholesterol
change in LDL-cholesterol
LDL-cholesterol
change in HDL-cholesterol
HDL-cholesterol
change in GIP
GIP
C-peptide
C-peptide
Homa-IR
Homa-IR
Homa-Percent Beta
Homa-Percent Beta
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03236116
First Posted
July 13, 2017
Last Updated
January 6, 2021
Sponsor
Purdue University
Collaborators
Almond Board of California
1. Study Identification
Unique Protocol Identification Number
NCT03236116
Brief Title
Almond Consumption and Glycemia
Official Title
Almond Consumption and Glycemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Almond Board of California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Appetite Disorders, Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Almond Group
Arm Type
Experimental
Arm Description
Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products.
Intervention Type
Other
Intervention Name(s)
Almonds
Intervention Description
Participants will consume almonds everyday for 6 months.
Intervention Type
Other
Intervention Name(s)
Control (no nuts)
Intervention Description
Participants will not be permited to consume any nuts for 6 months.
Primary Outcome Measure Information:
Title
HbA1c
Description
HbA1c.
Time Frame
Baseline
Title
fasting glucose
Description
fasting glucose,
Time Frame
Baseline
Title
fasting triglycerides
Description
fasting triglycerides
Time Frame
Baseline
Title
Change in Body weight
Description
Body weight
Time Frame
Every two weeks for 6 months.
Title
Body composition
Description
Body composition
Time Frame
Baseline
Title
GLP-1
Description
GLP-1
Time Frame
Baseline
Title
Change in HbA1c
Description
HbA1c.
Time Frame
6 months
Title
Change in fasting glucose
Description
fasting glucose
Time Frame
6 months
Title
fasting triglycerides
Description
fasting triglycerides
Time Frame
6 months
Title
Change in Body composition
Description
Body composition
Time Frame
6 months
Title
Change in GLP-1
Description
GLP-1
Time Frame
6 months
Title
fasting insulin
Description
fasting insulin
Time Frame
Baseline
Title
total cholesterol
Description
total cholesterol
Time Frame
Baseline
Title
LDL-cholesterol
Description
LDL-cholesterol
Time Frame
Baseline
Title
HDL-cholesterol
Description
HDL-cholesterol
Time Frame
Baseline
Title
GIP
Description
GIP
Time Frame
Baseline
Title
change in fasting insulin
Description
fasting insulin
Time Frame
6 months
Title
change in total cholesterol
Description
total cholesterol
Time Frame
6 months
Title
change in LDL-cholesterol
Description
LDL-cholesterol
Time Frame
6 months
Title
change in HDL-cholesterol
Description
HDL-cholesterol
Time Frame
6 months
Title
change in GIP
Description
GIP
Time Frame
6 months
Title
C-peptide
Time Frame
baseline
Title
C-peptide
Time Frame
6 months
Title
Homa-IR
Time Frame
baseline
Title
Homa-IR
Time Frame
6 months
Title
Homa-Percent Beta
Time Frame
Baseline
Title
Homa-Percent Beta
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Diet Quality
Description
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.
Time Frame
Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Title
Compliance
Description
Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.
Time Frame
Baseline, month 2, 4, and 6.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Not meeting one of the body fat distribution criteria
allergic to nuts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Mattes, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47909
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Almond Consumption and Glycemia
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