Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hyperlipidemia, Hyperglycemia, Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Adlay with white rice
* Dietary Supplement: white rice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Secondary hyperglycemia Secondary hyperlipidemia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adlay with white rice<br>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<br>* We will investigate the lipid- and glucose-lowering effects of Adlay rice in comparison to white rice through a randomized cross-over trial.<br>|
| Placebo Comparator: White rice<br>Group B ate a box of 200 grams of cooked white rice per day | Dietary Supplement: white rice<br>* white rice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | physiological biomarkers | 2 weeks for each stage | 
| Body composition | The percentages of fat, bone and muscle in human bodies by bioelectric impedance technology | 2 weeks for each stage | 
| hs-CRP (high sensitivity C-reactive protein) | Inflammation | 2 weeks for each stage | 
| Free T4 and TSH (Thyroid Stimulating Hormone) | Thyroid function tests | 2 weeks for each stage | 
| Insulin | A peptide hormone produced by beta cells of the pancreatic islets | 2 weeks for each stage | 
| Gastrin, Cholecystokinine, and Glucagon-like peptide 1 | Intestin Hormones | 2 weeks for each stage | 
| Small-dense LDL-cholesterol | LDL subpopulation particles | 2 weeks for each stage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adlay, Hyperlipidemia, Hyperglycemia