Menu
Recruiting NCT03375866

Effects of Mixed Nut Consumption on Satiety and Weight Management

No phase Interventional Satiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pretzels, Mixed nuts.
Who it may be relevant to
Registry conditions: Satiety. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Pretzels
    Subjects consume 240 kcal of pretzels daily for 16 weeks.
  • Other Mixed nuts
    Subjects consume 240 kcal of mixed nuts daily for 16 weeks.

Primary outcome measures

  • Change of Satiety [Time frame: 0, 20, 40, 60, 90 and 120 minutes post snack consumption]
  • Change of glucose level [Time frame: Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption]
  • Change of insulin level [Time frame: Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption]
  • Change of cholesterol levels [Time frame: 8 weeks and 16 weeks post daily consumption]
  • Change of Lp(a) [Time frame: 8 weeks and 16 weeks post daily consumption]
Secondary outcome measures (1)
  • Change of microbiome [Time frame: 8 weeks and 16 weeks post daily consumption]

Eligibility criteria

Inclusion criteria

  • 18-55 years old
  • BMI 27-40

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • School of Exercise and Nutritional Sciences, SDSU — San Diego

Publications

  • 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. PMID 37263914
  • 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. PMID 37083461

Identifiers

NCT: NCT03375866 · 2515098

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗