Effects of Mixed Nut Consumption on Satiety and Weight Management

Satiety Clinical Trial

Official title:

Effects of Mixed Nut Consumption on Satiety and Weight Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03375866
• Other study ID #: 2515098
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: San Diego State University
• Contact: Mee Young Hong
• Phone: 619-594-2392
• Email: mhong2[@]mail.sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Satiety

Intervention

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

Locations

Country	Name	City	State
United States	School of Exercise and Nutritional Sciences, SDSU	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change of cholesterol levels	Cholesterol levels will be examined using a biochemical method	8 weeks and 16 weeks post daily consumption
Primary	Change of Lp(a)	Lp(a) levels will be examined using an ELISA biochemical method	8 weeks and 16 weeks post daily consumption
Secondary	Change of microbiome	Diversity of microbiome will be analyzed in fecal samples	8 weeks and 16 weeks post daily consumption