Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control

Type 2 Diabetes Clinical Trial

— ADL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990595
• Other study ID #: 202206033RINC
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: Ta-Chen Su, MD, PhD
• Phone: +886-972651062
• Email: tachensu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Adlay 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.
• white rice
white rice

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh Sleep Quality Index	Sleep quality assessment	2 weeks for each stage
Other	Center for Epidemiologic Studies Depression Scale (CES-D), NIMH	Depression scale assessment	2 weeks for each stage
Primary	Fasting blood glucose	glucose-lowering effects	2 weeks for each stage
Primary	Cholesterol	Lipids	2 weeks for each stage
Primary	HDL-cholesterol	Lipids	2 weeks for each stage
Primary	LDL-cholesterol	Lipids	2 weeks for each stage
Primary	Triglycerides	Lipids	2 weeks for each stage
Primary	Glycosylated hemoglobin (HbA1C)	Hemoglobin A1C is a form of hemoglobin (Hb) that is chemically linked to sugar	2 weeks for each stage
Secondary	Blood pressure	physiological biomarkers	2 weeks for each stage
Secondary	Body composition	The percentages of fat, bone and muscle in human bodies by bioelectric impedance technology	2 weeks for each stage
Secondary	hs-CRP (high sensitivity C-reactive protein)	Inflammation	2 weeks for each stage
Secondary	Free T4 and TSH (Thyroid Stimulating Hormone)	Thyroid function tests	2 weeks for each stage
Secondary	Insulin	A peptide hormone produced by beta cells of the pancreatic islets	2 weeks for each stage
Secondary	Gastrin, Cholecystokinine, and Glucagon-like peptide 1	Intestin Hormones	2 weeks for each stage
Secondary	Small-dense LDL-cholesterol	LDL subpopulation particles	2 weeks for each stage