NCT03375866

Brief Summary

The first goal of the proposed study is to determine acute and long-term effects of mixed nuts (almonds, hazelnuts, pecans, pistachios, walnuts, and peanuts) on metabolic parameters and weight management. While numerous studies have shown the beneficial effects of nuts on promoting negative energy balance and weight loss, mechanistic studies exploring how the inclusion of nuts in the diet promotes a negative energy balance and weight loss have not been conducted. The second goal is to determine the mechanisms by which mixed nut consumption regulates of food intake and body weight.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress79%
Dec 2016Dec 2028

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

12 years

First QC Date

December 11, 2017

Last Update Submit

January 16, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change of Satiety

    Hunger feeling (appetite) will be examined using visual analog scale (0-10): 0 least and 10 greatest

    0, 20, 40, 60, 90 and 120 minutes post snack consumption

  • Change of glucose level

    Glucose level will be examined using glucose analysis

    Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption

  • Change of insulin level

    Insulin level will be examined using an ELISA biochemical method

    Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption

  • Change of cholesterol levels

    Cholesterol levels will be examined using a biochemical method

    8 weeks and 16 weeks post daily consumption

  • Change of Lp(a)

    Lp(a) levels will be examined using an ELISA biochemical method

    8 weeks and 16 weeks post daily consumption

Secondary Outcomes (1)

  • Change of microbiome

    8 weeks and 16 weeks post daily consumption

Study Arms (2)

Pretzels

ACTIVE COMPARATOR
Other: Pretzels

Mixed nuts

EXPERIMENTAL
Other: Mixed nuts

Interventions

Subjects consume 240 kcal of pretzels daily for 16 weeks.

Pretzels

Subjects consume 240 kcal of mixed nuts daily for 16 weeks.

Mixed nuts

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • BMI 27-40

You may not qualify if:

  • Smoker
  • Pregnant woman
  • Required dietary supplement use
  • Required medication of metabolic disorders
  • Allergy to nuts or gluten

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Exercise and Nutritional Sciences, SDSU

San Diego, California, 92182-7251, United States

RECRUITING

Related Publications (2)

  • Nora CL, Zhang L, Castro RJ, Marx A, Carman HB, Lum T, Tsimikas S, Hong MY. Effects of mixed nut consumption on LDL cholesterol, lipoprotein(a), and other cardiometabolic risk factors in overweight and obese adults. Nutr Metab Cardiovasc Dis. 2023 Aug;33(8):1529-1538. doi: 10.1016/j.numecd.2023.05.013. Epub 2023 May 15.

  • Rosas M Jr, Liu C, Hong MY. Effects of Mixed Nut Consumption on Blood Glucose, Insulin, Satiety, and the Microbiome in a Healthy Population: A Pilot Study. J Med Food. 2023 May;26(5):342-351. doi: 10.1089/jmf.2022.0121. Epub 2023 Apr 20.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 18, 2017

Study Start

December 1, 2016

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations