NCT02542176

Brief Summary

The purpose of this study is to evaluate the effects of both chronic and acute grape ingestion in a population of men and women at higher risk for both type 2 diabetes and cardiovascular disease (metabolic syndrome).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

September 1, 2015

Last Update Submit

March 22, 2018

Conditions

Metabolic Syndrome X

Keywords

Metabolic SyndromeGrapeHDLLipoproteins

Outcome Measures

Primary Outcomes (1)

  • Fasted HDL-cholesterol

    Measurement of plasma HDL-cholesterol (mg/dL) at the end of each 4-week intervention arms.

    13 weeks

Secondary Outcomes (3)

  • Fasted apolipoprotein B-depleted serum cholesterol efflux capacity

    13 weeks

  • Postprandial HDL anti-inflammatory activity

    On first day of each intervention arm up to 6 hours after test meal

  • Postprandial HDL antioxidant activity

    On first day of each intervention arm up to 6 hours after test meal

Study Arms (2)

Freeze-dried Whole Grape Powder

EXPERIMENTAL
Other: Freeze-dried Whole Grape Powder

Grape Powder Placebo

PLACEBO COMPARATOR
Other: Grape Powder Placebo

Interventions

Freeze-dried Whole Grape PowderOTHER

60 g of whole grape powder for 4 weeks

Freeze-dried Whole Grape Powder
Grape Powder PlaceboOTHER

60 g of grape powder placebo for 4 weeks

Grape Powder Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30 to 70 years
  • Having metabolic syndrome, meaning that subjects have at least 3 of the following characteristics:
  • Waist circumference ≥ 102 cm for men and ≥ 88 cm for women
  • Triglycerides ≥ 150 mg/dL
  • HDL cholesterol \< 40 mg/dL for men and \< 50 mg/dL for women
  • Blood pressure ≥ 130/85 mm Hg or taking an anti-hypertensive medication
  • Fasting blood glucose ≥ 100 mg/dL

You may not qualify if:

  • Do not fulfill the classification of metabolic syndrome
  • History of diabetes mellitus, cardiovascular disease, stroke, renal problems, liver disease, endocrine disorder, inborn error of metabolism, eating disorder or cancer.
  • Weight loss greater than 10% of body weight over preceding 4 weeks.
  • Taking high-dose aspirin (≥150 mg/day) or anti-inflammatory prescriptions, or any triglyceride- or glucose-lowering prescriptions or supplements, such as insulin, sodium-glucose transport protein-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, Fibrates (e.g., fenofibrates, gemfibrozil), Niacin (e.g., high dose nicotinic acid, Niaspan) Sulphonylureas (e.g., Glucotrol, Amaryl), Thiazolidinediones (e.g., Avandia, ACTOS, Rezulin), Meglitinides (e.g., Prandin, Starlix), Biguanides (e.g., Metformin), Alpha-glucosidase inhibitors (e.g., Precose, Glyset), dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., Januvia, Onglyza), prescription fish oil (e.g., Lovaza, Vascepa), high dose chromium, high dose fish oil, or cinnamon supplements etc.
  • Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, blood pressure higher than 160/100 mmHg, and waist circumference higher than 200 cm.
  • Allergy to coconut, milk, wheat, grapes or an allergy/intolerance to the placebo ingredients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

  • Millar CL, Duclos Q, Garcia C, Norris GH, Lemos BS, DiMarco DM, Fernandez ML, Blesso CN. Effects of Freeze-Dried Grape Powder on High-Density Lipoprotein Function in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Study. Metab Syndr Relat Disord. 2018 Nov;16(9):464-469. doi: 10.1089/met.2018.0052. Epub 2018 Aug 21.

    PMID: 30129815DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 4, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

US(1)