NCT01950806

Brief Summary

The objective of this randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity, inflammation, endothelial function, and insulin resistance when compared with a control diet that is absent nuts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

September 23, 2013

Last Update Submit

April 24, 2017

Conditions

Cardiovascular Disease RiskType 2 Diabetes Risk

Outcome Measures

Primary Outcomes (5)

  • Change in biomarkers of oxidative stress compared with control diet

    Baseline and 4 weeks

  • Change in biomarkers of inflammation compared with control diet

    Baseline and 4 weeks.

  • Change in biomarkers of endothelial function compared with control diet

    Baseline and 4 weeks.

  • Change in biomarkers of antioxidant activity compared with control diet

    Baseline and 4 weeks

  • Change in biomarkers of insulin resistance compared with control diet

    Baseline and 4 weeks

Secondary Outcomes (2)

  • Change in blood pressure compared with control diet

    Baseline and 4 weeks

  • Change in plasma lipid profile compared with control diet

    Baseline and 4 weeks.

Study Arms (2)

Pecan-containing diet

ACTIVE COMPARATOR

Test diet containing 1.5 oz pecans/2000 kcal/day for 28 days

Other: Pecan-containing diet

Nut-free diet

PLACEBO COMPARATOR

Placebo diet containing no nuts or nut products, and identical in total fat and fiber as the test diet, for 28 days

Other: Nut-free diet

Interventions

Pecan-containing dietOTHER
Also known as: Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days
Pecan-containing diet
Nut-free dietOTHER
Also known as: Isocaloric diet absent nuts and matched for total fat and fiber for 28 days.
Nut-free diet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men \& postmenopausal women, age 50 years and over
  • BMI 25-35 kg/m2
  • Waist/hip \>0.8 for women and \>0.9 for men
  • Blood pressure between 120/80 and 159/99

You may not qualify if:

  • Cigarette smoking and/or nicotine replacement use
  • Individuals taking estrogen
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications (prescription or over-the-counter \[OTC\])
  • Cardiovascular (heart) disease
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, unstable thyroid disease
  • Autoimmune disease: including rheumatoid arthritis, gout, lupus, HIV
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure \> 159 mmHg and/or diastolic blood pressure \> 99 mmHg
  • Regular use of oral or injectable steroids
  • Gain or loss of \> 10% of body weight within previous 3 months; unwillingness to maintain your weight
  • Regular daily intake of ≥ 2 alcoholic drinks
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

US(1)