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Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control

Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control (ADL)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990595
Acronym
ADL
Enrollment
60
Registered
2023-08-14
Start date
2023-07-07
Completion date
2023-11-30
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hyperglycemia, Type 2 Diabetes

Keywords

Adlay, Hyperlipidemia, Hyperglycemia

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.

Detailed description

Evaluation of health effects of domestic adlay on lowering cholesterol and blood sugar Hyperlipidemia and diabetes are major risk factors for cardiovascular disease. Clinical experiments have preliminarily proved that phytosterols can help lower blood lipids, and adlay is one of the domestic economic crops that has animal experimental evidence or theoretical potential to be beneficial to blood lipids and blood sugar control, which needs to be further explored and verified. 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. We plan to recruit 60 patients with hyperglycemia or hyperlipidemia. aged between 20 and 80 years old, from National Taiwan University Hospital. This study is focused on high blood cholesterol, triglycerides, and hyperglycemia groups, thus participants must have higher cholesterol, triglycerides, or higher fasting blood glucose concentration even under currently stable treatment for at least 6 months. Lipid-lowering and hypoglycemic medication cannot be changed during this trial. 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 adlay to replace their carbohydrates: a box of 200 grams of rice (the amount of rice in dry weight is 36 grams of adlay and 54 grams of white rice) per day; Group B ate a box of 200 grams of white rice (the amount of rice was 87 grams based on dry weight) 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. To ensure that the test material is homogeneous and uniform, the white rice with adlay is made from the cooked rice with adlay produced by Nanqiao Group, HUACIANG INDUSTRY CO., LTD. The adlay cooked rice contains 40% adlay and Taichung No. 194 white rice 60%, and the control group used Taichung No. 194 white rice. Every participant have to receive blood and urine sampling for biochemical measurement in each stage, 1. Baseline, 2. Two weeks after first stage: adlay with white rice or white rice, 3. Washed period stage for 2 weeks, 4. Two weeks after crossover stage. The main results analysis includes fasting blood sugar,glycosylated hemoglobin, glycosylated hemoglobin, triglycerides, total cholesterol, high-density cholesterol, and low-density cholesterol. Secondary outcome analysis includes blood pressure, body composition analysis, inflammation index, thyroid function, levels of intestinal hormones (cholecystokinin, gastrin) and glucagon-like peptide-1, and other emerging blood lipid indicators, such as small-dense LDL-C. The above measurements will be performed every 2 weeks for each stage. Pittsburgh Sleep Quality Index and Center for Epidemiological Studies Depression Scale (CES-D) will also be assessed every 2 weeks for each stage. Keywords: hyperlipidemia, hyperglycemia, diabetes mellitus, randomized crossover trial

Interventions

DIETARY_SUPPLEMENTAdlay with white rice

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

DIETARY_SUPPLEMENTwhite rice

white rice

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Hyperlipidemia: Levels of LDL-choleterol equal or greater than 130 mg/dL, or triglyceride equal or greater than 150 mg/dL 2. Hyperglycemia: fasting glucose equal or greater than 100 mg/dL

Exclusion criteria

Secondary hyperglycemia Secondary hyperlipidemia

Design outcomes

Primary

MeasureTime frameDescription
Triglycerides2 weeks for each stageLipids
Glycosylated hemoglobin (HbA1C)2 weeks for each stageHemoglobin A1C is a form of hemoglobin (Hb) that is chemically linked to sugar
Fasting blood glucose2 weeks for each stageglucose-lowering effects
Cholesterol2 weeks for each stageLipids
HDL-cholesterol2 weeks for each stageLipids
LDL-cholesterol2 weeks for each stageLipids

Secondary

MeasureTime frameDescription
Small-dense LDL-cholesterol2 weeks for each stageLDL subpopulation particles
Gastrin, Cholecystokinine, and Glucagon-like peptide 12 weeks for each stageIntestin Hormones
Free T4 and TSH (Thyroid Stimulating Hormone)2 weeks for each stageThyroid function tests
Blood pressure2 weeks for each stagephysiological biomarkers
Body composition2 weeks for each stageThe percentages of fat, bone and muscle in human bodies by bioelectric impedance technology
hs-CRP (high sensitivity C-reactive protein)2 weeks for each stageInflammation
Insulin2 weeks for each stageA peptide hormone produced by beta cells of the pancreatic islets

Other

MeasureTime frameDescription
Pittsburgh Sleep Quality Index2 weeks for each stageSleep quality assessment
Center for Epidemiologic Studies Depression Scale (CES-D), NIMH2 weeks for each stageDepression scale assessment

Countries

Taiwan

Contacts

Primary ContactTa-Chen Su, MD, PhD
tachensu@gmail.com+886-972651062
Backup ContactCheng-Yu Chiang, MSc
oldchiang@gmail.com+886-965813735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026