Clinical trial NCT05990595: Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control
Official title: Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control (ADL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperlipidemia
Hyperglycemia
Type 2 Diabetes
Keywords: Adlay, Hyperlipidemia, Hyperglycemia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Fasting blood glucose
timeFrame: 2 weeks for each stage
measure: Cholesterol
timeFrame: 2 weeks for each stage
measure: HDL-cholesterol
timeFrame: 2 weeks for each stage
measure: LDL-cholesterol
timeFrame: 2 weeks for each stage
measure: Triglycerides
timeFrame: 2 weeks for each stage
measure: Glycosylated hemoglobin (HbA1C)
timeFrame: 2 weeks for each stage
Secondary outcomes:
measure: Blood pressure
timeFrame: 2 weeks for each stage
measure: Body composition
timeFrame: 2 weeks for each stage
measure: hs-CRP (high sensitivity C-reactive protein)
timeFrame: 2 weeks for each stage
measure: Free T4 and TSH (Thyroid Stimulating Hormone)
timeFrame: 2 weeks for each stage
measure: Insulin
timeFrame: 2 weeks for each stage
measure: Gastrin, Cholecystokinine, and Glucagon-like peptide 1
timeFrame: 2 weeks for each stage
measure: Small-dense LDL-cholesterol
timeFrame: 2 weeks for each stage
Other outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 2 weeks for each stage
measure: Center for Epidemiologic Studies Depression Scale (CES-D), NIMH
timeFrame: 2 weeks for each stage
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ta-Chen Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: