A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels

NCT02769741 | Completed DMC

• 1 other identifier: BIO-1509
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol.

Conditions

Healthy Volunteers

Keywords

Cashew; Lipoprotein

Outcome Measures

Primary Outcomes (1)

• Change in LDL-C concentration measured in blood

  % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

Secondary Outcomes (5)

• Total cholesterol change

  % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

• HDL-cholesterol change

  % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

• Non-HDL-cholesterol change

  % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

• Triglyceride change

  % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

• Total cholesterol/HDL-cholesterol ratio change

  % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

Study Arms (2)

Crossover 1: Control Diet followed by Active Diet

OTHER

Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts

Other: Control followed by Cashews

Crossover 2: Active Diet followed by Control Diet

OTHER

Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts

Other: Cashews followed by Control

Interventions

Cashews followed by Control OTHER

Participants will receive the active diet with cashew nuts as a daily snack during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the control diet at the same calorie level, but with a control snack instead of cashew nuts during Test Period II.

Crossover 2: Active Diet followed by Control Diet

Control followed by Cashews OTHER

Participants will receive a controlled diet without cashew nuts during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the active diet at the same calorie level, but with cashew nuts as a daily snack during Test Period II.

Crossover 1: Control Diet followed by Active Diet

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI of ≥18.00 and ≤32.00 kg/m\^2
• Fasting LDL-C level ≥130 mg/dL and \<200 mg/dL
• Fasting TG ≤350 mg/dL

You may not qualify if:

• CHD or CHD risk equivalent
• Pregnancy
• Use of lipid altering medications which cannot be stopped
• Certain liver, kidney, lung, or gastrointestinal conditions
• Poorly controlled hypertension
• Certain medications
• Allergy or sensitivity to nuts or other food/beverage or food/beverage component
• Active cancers treated within prior 2 years (except non-melanoma skin cancer)
• Significant weight loss or gain within prior 3 months

Sponsors & Collaborators

• Kraft Heinz Company: lead
• BioFortis: collaborator

Related Publications (1)

• Mah E, Schulz JA, Kaden VN, Lawless AL, Rotor J, Mantilla LB, Liska DJ. Cashew consumption reduces total and LDL cholesterol: a randomized, crossover, controlled-feeding trial. Am J Clin Nutr. 2017 May;105(5):1070-1078. doi: 10.3945/ajcn.116.150037. Epub 2017 Mar 29.

  PMID: 28356271 DERIVED

Study Officials

• Andrea Lawless, MD

  BioFortis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 12, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10