NCT03126981

Brief Summary

The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice daily on insulin sensitivity and markers of cardiometabolic health in men and women with prediabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

April 20, 2017

Last Update Submit

July 23, 2019

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity index (SI)

    SI from a short (50-min) intravenous glucose tolerance test (IVGTT) at baseline(day 0) and end of two treatment periods (day 43 of both treatment periods)

    43 days for each treatment period.

Secondary Outcomes (5)

  • Fasting lipoprotein lipids

    Up to 43 days for each treatment period.

  • Apolipoprotein (Apo) B and A1, Lipoprotein subfractions and particles

    43 days for each treatment period

  • high-sensitivity C-reactive protein (hs-CRP)

    Up to 43 days

  • Serum Uric acid

    43 days for each treatment period

  • Interleukin-6 (IL-6)

    43 days for each treatment period

Study Arms (2)

Whole, natural almonds

EXPERIMENTAL

1.5 oz of whole, natural almonds

Other: 1.5 oz of whole, natural almonds

Low-fat, high refined starches/sugars

PLACEBO COMPARATOR

Low-fat foods,high in refined starches and added sugars

Other: Low-fat, high refined starches/sugars

Interventions

1.5 oz of whole, natural almondsOTHER

1.5 oz of whole, natural almonds

Whole, natural almonds
Low-fat, high refined starches/sugarsOTHER

Low-fat foods, high in refined starches and added sugars

Low-fat, high refined starches/sugars

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 25.0-39.9 kg/m2
  • Prediabetic: fingerstick glycated hemoglobin 5.7-6.4% (inclusive), or fasting fingerstick capillary glucose of 100-125 mg/dL (inclusive), or 2-h post-prandial glucose of 140-199 mg/dL.
  • Fasting LDL-C level \<200 mg/dL and fasting TG level \<400 mg/dL.
  • Judged to be in general good health on the basis of medical history and screening laboratory tests.

You may not qualify if:

  • Atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease \[symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or \>50% stenosis on angiography or ultrasound\], history of myocardial infarction, angina, a revascularization procedure, or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
  • History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type I or type II diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
  • Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
  • Uncontrolled hypertension.
  • Recent history of cancer, except for non-melanoma skin cancer.
  • Recent change in body weight of ± 4.5 kg (9.9 lbs).
  • Recent use of any medications intended to alter the lipid profile (e.g. bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or PCSK9 inhibitors, with the exception of the stable use of statins), weight-loss drugs or programs, systemic corticosteroid drugs, unstable use of any antihypertensive medication; medications known to influence CHO metabolism (e.g. adrenergic receptor blockers, diuretics, and/or hypoglycemic medications).
  • Recent use of food/supplements known to influence lipid metabolism (e.g. omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses \>400 mg/d, and irregular or inconsistent use of Metamucil® or viscous fiber-containing supplements.
  • Recent use of antibiotics.
  • Pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  • Extreme dietary habits (e.g. very low CHO diet, vegan, etc.).
  • Current or recent history, or strong potential, for drug or alcohol abuse.
  • History of a diagnosed eating disorder. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MB Clinical Research

Boca Raton, Florida, 33487, United States

Location

Illinois Institute for Food Safety and Health (IFSH) at Illinois Instiute of Technology (IIT)

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

  • Palacios OM, Maki KC, Xiao D, Wilcox ML, Dicklin MR, Kramer M, Trivedi R, Burton-Freeman B, Edirisinghe I. Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes. J Am Coll Nutr. 2020 Jul;39(5):397-406. doi: 10.1080/07315724.2019.1660929. Epub 2019 Sep 16.

    PMID: 31525129DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Diet, Fat-RestrictedSugars

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaCarbohydrates

Study Officials

  • Kevin Maki, PhD

    MB Clinical Research and Consulting LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 25, 2017

Study Start

April 20, 2017

Primary Completion

September 26, 2018

Study Completion

September 26, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)