NCT05990595

Brief Summary

This study explores the efficacy of domestic adlay in improving blood sugar and lipids metabolism, cardiovascular function, and weight control in people with high blood pressure, hyperlipidemia, and hyperglycemia. Through two weeks of cooked adlay-rice and white rice by a randomized cross-over design to evaluate the lipid- and glucose-lowering effects of adlay on patient with hyperlipidemia and/or hyperglycemia.

Trial Health

43
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 Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 7, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 21, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 24, 2023

Last Update Submit

August 17, 2023

Conditions

HyperlipidemiaHyperglycemiaType 2 Diabetes

Keywords

Adlay, Hyperlipidemia, Hyperglycemia

Outcome Measures

Primary Outcomes (6)

  • Fasting blood glucose

    glucose-lowering effects

    2 weeks for each stage

  • Cholesterol

    Lipids

    2 weeks for each stage

  • HDL-cholesterol

    Lipids

    2 weeks for each stage

  • LDL-cholesterol

    Lipids

    2 weeks for each stage

  • Triglycerides

    Lipids

    2 weeks for each stage

  • Glycosylated hemoglobin (HbA1C)

    Hemoglobin A1C is a form of hemoglobin (Hb) that is chemically linked to sugar

    2 weeks for each stage

Secondary Outcomes (7)

  • Blood pressure

    2 weeks for each stage

  • Body composition

    2 weeks for each stage

  • hs-CRP (high sensitivity C-reactive protein)

    2 weeks for each stage

  • Free T4 and TSH (Thyroid Stimulating Hormone)

    2 weeks for each stage

  • Insulin

    2 weeks for each stage

  • +2 more secondary outcomes

Other Outcomes (2)

  • Pittsburgh Sleep Quality Index

    2 weeks for each stage

  • Center for Epidemiologic Studies Depression Scale (CES-D), NIMH

    2 weeks for each stage

Study Arms (2)

Adlay with white rice

EXPERIMENTAL

Group A eat cooked adlay with white rice to replace their carbohydrates: a box of 200 grams of adlay rice per day

Dietary Supplement: Adlay with white rice

White rice

PLACEBO COMPARATOR

Group B ate a box of 200 grams of cooked white rice per day

Dietary Supplement: white rice

Interventions

Adlay with white riceDIETARY_SUPPLEMENT

We will investigate the lipid- and glucose-lowering effects of Adlay rice in comparison to white rice through a randomized cross-over trial.

Adlay with white rice
white riceDIETARY_SUPPLEMENT

white rice

White rice

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperlipidemia: Levels of LDL-choleterol equal or greater than 130 mg/dL, or triglyceride equal or greater than 150 mg/dL
  • Hyperglycemia: fasting glucose equal or greater than 100 mg/dL

You may not qualify if:

  • Secondary hyperglycemia Secondary hyperlipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

HyperlipidemiasHyperglycemiaDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ta-Chen Su, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ta-Chen Su, MD, PhD

CONTACT

+886-972651062tachensu@gmail.com

Cheng-Yu Chiang, MSc

CONTACT

+886-965813735oldchiang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The clinical trial adopts a randomized cross-over trial, the experimental group to eat white rice with adlay and the control group to eat white rice. Participants in the project were randomly divided into two groups, group A and B, with 30 people in each group. Group A eat 200 gm cooked adlay with white rice to replace their carbohydrates; Group B ate a box of 200 grams of white rice per day. After the first run of study, all participants resume to the original regular diet for two weeks, and then switch groups for crossover trial after the two-week washout period. In the experiment, during the crossover experiment, group A and group B replaced the experimental ingredients, that is, the original white rice group was replaced by adlay with white rice, and the original adlay and white rice group was replaced with white rice for a period of two weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 14, 2023

Study Start

July 7, 2023

Primary Completion

September 28, 2023

Study Completion

November 30, 2023

Last Updated

August 21, 2023

Record last verified: 2023-07

Locations

TW(1)