Potato Diet Intervention Study in a College Population

NCT ID: NCT06686199

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-06-01

Brief Summary

The goal of this study is to investigate the effects of a potato-based diet intervention on Chinese university students. Employing a randomized controlled double-blind trial design, the intervention will span 8 weeks. The primary objectives include:

• Examining the impact of the potato-based diet intervention on the overall glucose and lipid metabolism levels of university students;
• Exploring the interactions between the potato-based diet intervention and individual metabolic profiles and glucose-lipid metabolic pathways;
• Analyzing the association between the potato-based diet intervention and gut health through gut microbiota analysis.

Participants will undergo either the potato-based diet intervention or the control group treatment. Changes in waist circumference, blood pressure, blood glucose, and blood lipid levels will be observed to assess the effects of the potato-based diet on university students' health. Additionally, alterations in metabolic profiles and glucose-lipid metabolic pathways will be analyzed, along with gut microbiota analysis, to investigate the relationship between the potato-based diet and gut health.

Detailed Description

This study aims to recruit young adults aged 18-35 from university populations who meet the criteria and are willing to participate. After screening based on baseline information, eligible volunteers will be randomly assigned to two groups: an intervention group and a control group. The intervention group will consume fried potatoes, while the control group will consume steamed potatoes, at a daily dose of 135g, 4-5 times a week, for an 8-week dietary intervention period.

1. The effects of potato-based dietary intervention on the metabolic profiles of glucose and lipids in the human body will be assessed. General indicators such as height, weight, blood pressure, waist circumference, and hip circumference will be measured at baseline and at the intervention endpoint for all participants. Fasting blood samples will be collected to measure four lipid parameters (TG, TC, LDL-C, HDL-C), fasting blood glucose, fasting insulin, glycosylated hemoglobin levels, and serum C-peptide levels. Changes and differences in glucose and lipid metabolism indicators among groups will be observed.

2. The role of potato-based dietary intervention on the blood metabolic profiles, gut microbiota composition, and inflammatory response in university student populations will be investigated. Blood and stool samples will be collected to study the effects of potato-based dietary intervention on metabolic markers of glucose and lipids in biological samples and the gut microbiota composition in fecal samples. The analysis will focus on its effects on serum inflammatory factors by influencing glucose and lipid metabolism pathways and gut microbiota composition, as well as inflammatory signaling pathways, elucidating the mechanisms through which it modulates glucose and lipid metabolism.

Conditions

Metabolism and Nutrition Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Group Type: PLACEBO_COMPARATOR

steamed potato

Intervention Type: DIETARY_SUPPLEMENT

135 g per day 4-5 times per week for 8 weeks

Intervention group

Group Type: EXPERIMENTAL

fried potato

Intervention Type: DIETARY_SUPPLEMENT

135 g per day 4-5 times per week for 8 weeks

Interventions

steamed potato

135 g per day 4-5 times per week for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

fried potato

135 g per day 4-5 times per week for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• University students at school

Exclusion Criteria

• Smoking (≥1 cigarette/week);
• heavy alcohol consumption (>224 g/week for men and >168 g/week for women);
• diabetes, heart disease, stroke, high blood pressure, liver dysfunction, kidney dysfunction, or gastrointestinal disorders;
• taking dietary supplements (e.g., vitamins, minerals, probiotics, or prebiotics);
• taking medications (e.g., aspirin, statin, or antihypertensive medications);
• within the past 3 months taken antibiotics;
• had surgery in the past 3 months;
• participated in other clinical studies in the past 3 months;
• preference for fried and baked foods.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yu Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhang

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Yu Zhang

Role: CONTACT

yzhang@zju.edu.cn

86-0571-88982211

Other Identifiers

RCT_ Potato Meal

Identifier Type: -

Identifier Source: org_study_id