Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk

NCT03227497 | Completed

• 1 other identifier: EO120/2017
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk. Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks. The study subjects are instructed to continue with their habitual diet and physical activity.

Conditions

Cardiovascular Risk Factor; Metabolic Syndrome; Hypertension

Keywords

Blood Pressure; Cholesterol; Triglycerides; Walnuts

Outcome Measures

Primary Outcomes (3)

• Changes in LDL-cholesterol

  Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  Baseline, 5 weeks, 10 weeks

• Changes in Systolic Blood Pressure

  Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.

  Baseline, 5 weeks, 10 weeks

• Changes in Diastolic Blood Pressure

  Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.

  Baseline, 5 weeks, 10 weeks

Secondary Outcomes (17)

• Changes in HDL-cholesterol

  Baseline, 5 weeks, 10 weeks

• Changes in total cholesterol

  Baseline, 5 weeks, 10 weeks

• Changes in triglycerides

  Baseline, 5 weeks, 10 weeks

• Changes in glucose metabolism biomarkers

  Baseline, 5 weeks, 10 weeks

• Changes in renal function parameters

  Baseline, 5 weeks, 10 weeks

Study Arms (2)

Walnut

ACTIVE COMPARATOR

At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm). Treatment arm includes 56 g of whole walnuts daily.

Dietary Supplement: Whole Walnuts

Control

NO INTERVENTION

At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Interventions

Whole Walnuts DIETARY_SUPPLEMENT

Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.

Walnut

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least one of the following criteria, formerly assessed through routine medical examination:
• dyslipidemia, defined as the presence of either: elevated total cholesterol (\>5.2 mmoL/L), and/or elevated LDL-cholesterol (\>3.4 mmoL/L), and/or elevated triglycerides (\>1.7 mmoL/L), and/or decreased HDL-cholesterol (\<1.6 mmoL/L)
• elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy

You may not qualify if:

• presence of allergy on any nuts
• presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
• smoking
• statin therapy
• pregnancy and/or lactation

Sponsors & Collaborators

• University of Belgrade: lead
• Centre of Research Excellence in Nutrition and Metabolism: collaborator

Study Sites (1)

Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maria Glibetic, Prof

  Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Independent researcher will perform statistical analyses, without prior knowledge on study treatment allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This study is a randomized, cross-over, controlled, 5-week nutritional intervention, investigating health effects of dietary intake of whole walnuts, as a replacement meal within habitual diet and lifestyle. At the beginning of the study, half of the study subjects are randomly assigned to a treatment arm with walnut consumption, or control arm without study intervention. Treatment arm considers consumption of pre-packed 56 g of whole walnuts daily, as a replacement meal. After 5 weeks, study subjects are crossed, for additional 5 weeks. At the beginning of the study, all subjects are instructed to continue with their habitual diet and physical activity during the study period of 10 weeks.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 24, 2017
• Study Start: April 21, 2017
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)