This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
75
Participants will consume almonds everyday for 6 months.
Participants will not be permited to consume any nuts for 6 months.
Indiana University School of Medicine
Indianapolis, Indiana, United States
Purdue University
West Lafayette, Indiana, United States
Purdue University
West Lafayette, Indiana, United States
HbA1c
HbA1c.
Time frame: Baseline
fasting glucose
fasting glucose,
Time frame: Baseline
fasting triglycerides
fasting triglycerides
Time frame: Baseline
Change in Body weight
Body weight
Time frame: Every two weeks for 6 months.
Body composition
Body composition
Time frame: Baseline
GLP-1
GLP-1
Time frame: Baseline
Change in HbA1c
HbA1c.
Time frame: 6 months
Change in fasting glucose
fasting glucose
Time frame: 6 months
fasting triglycerides
fasting triglycerides
Time frame: 6 months
Change in Body composition
Body composition
Time frame: 6 months
Change in GLP-1
GLP-1
Time frame: 6 months
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fasting insulin
fasting insulin
Time frame: Baseline
total cholesterol
total cholesterol
Time frame: Baseline
LDL-cholesterol
LDL-cholesterol
Time frame: Baseline
HDL-cholesterol
HDL-cholesterol
Time frame: Baseline
GIP
GIP
Time frame: Baseline
change in fasting insulin
fasting insulin
Time frame: 6 months
change in total cholesterol
total cholesterol
Time frame: 6 months
change in LDL-cholesterol
LDL-cholesterol
Time frame: 6 months
change in HDL-cholesterol
HDL-cholesterol
Time frame: 6 months
change in GIP
GIP
Time frame: 6 months
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
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.
Time frame: 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.
Time frame: Baseline, month 2, 4, and 6.