NCT06686199

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 13, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 15, 2024

Last Update Submit

November 12, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in body weight from baseline

    The investigators will measure body weight before and after treatment.

    Time Frame: 2 months

  • Change in blood glucose from baseline

    The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.

    Time Frame: 2 months

  • Change in triglycerides from baseline

    The investigators will measure Triglyceride levels in blood samples before and after treatment.

    2 month

Secondary Outcomes (1)

  • Change in lipid indicators from baseline

    2 month

Study Arms (2)

Control group

PLACEBO COMPARATOR
Dietary Supplement: steamed potato

Intervention group

EXPERIMENTAL
Dietary Supplement: fried potato

Interventions

steamed potatoDIETARY_SUPPLEMENT

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

Control group
fried potatoDIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University students at school

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 15, 2024

First Posted

November 13, 2024

Study Start

March 3, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

November 13, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share