Avocado Fruit on Postprandial Markers of the Glycemic Response, Satiety/Appetite and Cardiometabolic Risk

NCT02479048 | Completed

• 1 other identifier: IRB2015-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal is to characterize the acute effects of avocado intake on glycemic and satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary goal is to investigate risk factors for cardio-metabolic disease.

Conditions

Glycemic Response

Keywords

satiety/appetite; glycemic response; cardiometabolic risk

Outcome Measures

Primary Outcomes (1)

• Change in postprandial blood glucose concentration response for treatments compared to control over 6-hour postprandial period

  postprandial blood glucose concentration response

  Baseline to 6 hours

Secondary Outcomes (4)

• Changes in postprandial endothelial function using Flow Mediated Dilation (FMD) for treatments compared to control

  Baseline to 6 hours

• Change in postprandial blood insulin and triglycerides concentration response for treatments compared to control over 6-hour postprandial period

  Baseline to 6 hours

• Changes in postprandial subjective satiety responses using visual analog scales (VAS) for treatments compared to control over 6-hour postprandial period

  Baseline to 6 hours

• Changes in postprandial gut hormones related to satiety for treatments compared to control over 6-hour postprandial period

  Baseline to 6 hours

Other Outcomes (3)

• Changes in postprandial lipoproteins responses for treatments compared to control

  Baseline to 6 hours

• Changes in postprandial inflammation responses for treatments compared to control

  Baseline to 6 hours

• Changes in postprandial oxidation responses for treatments compared to control

  Baseline to 6 hours

Study Arms (3)

Test meal 1 (TM1)

ACTIVE COMPARATOR

High fat meal (HF) with ½ avocado (\~68g)

Dietary Supplement: Test meal 1

Test meal 2 (TM2)

ACTIVE COMPARATOR

High fat meal (HF) with 1 avocado (\~136g)

Dietary Supplement: Test meal 2

Control meal (CM)

PLACEBO COMPARATOR

High carbohydrate, high saturated fat control meal (CM) without avocado.

Dietary Supplement: Control Meal (CM)

Interventions

Test meal 1 DIETARY_SUPPLEMENT

High fat meal (HF) with ½ avocado (\~68g), matched to CM for energy content; not matched for macronutrient content or type (e.g., fat type).

Test meal 1 (TM1)

Test meal 2 DIETARY_SUPPLEMENT

High fat meal (HF) with 1 avocado (\~136g) matched for energy but not macronutrient content or type.

Test meal 2 (TM2)

Control Meal (CM) DIETARY_SUPPLEMENT

High carbohydrate, high saturated fat control meal (CM) without avocado.

Control meal (CM)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 25-60 yrs.
• BMI of 25 - 35 kg/m2
• No clinical evidence / history of cardiovascular, respiratory, renal, gastrointestinal, or hepatic disease
• Not taking over-the-counter or prescription medications / dietary supplements that may interfere with study procedures or endpoints (e.g., antioxidant supplements, anti-inflammatory, lipid-lowering or blood pressure lowering medications.
• Fasting blood glucose of 90-115 mg/dl
• Fasting insulin \< 13 U/L
• Non-smoker or past smoker (smoking cessation \> 2 yrs.)
• has at least 1 large, sturdy and well anchored vein in order to place a catheter

You may not qualify if:

• Aged \< 25 or \> 60 years
• BMI \< 25 kg/m2 or \> 35 kg/m2
• History of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease
• Diabetes
• Uncontrolled blood pressure (\>140 / 90 mmHg)
• Have or had cancer other than non-melanoma skin cancer in past 5 years
• Taking over-the-counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints (including protein powers, energy drinks)
• Fasting blood glucose \<90 or \> 115 mg/dl
• Fasting insulin ≥ 13 U/L
• Vegan dietary habits, unusual dietary habits or sensitive or allergic to any of the test meal components / ingredients
• Dislike avocados or non-consumers of avocados
• Current smoker
• Actively losing weight or trying to lose weight
• Drug or alcohol addiction
• Present with significant psychiatric or neurological disturbances

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)