ADL: Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05990595
Collaborator
(none)
60
1
2
4.8
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Adlay with white rice
  • Dietary Supplement: white rice
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control (ADL)
Actual Study Start Date :
Jul 7, 2023
Anticipated Primary Completion Date :
Sep 28, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adlay with white rice

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

Placebo Comparator: White rice

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

Dietary Supplement: white rice
white rice

Outcome Measures

Primary Outcome Measures

  1. Fasting blood glucose [2 weeks for each stage]

    glucose-lowering effects

  2. Cholesterol [2 weeks for each stage]

    Lipids

  3. HDL-cholesterol [2 weeks for each stage]

    Lipids

  4. LDL-cholesterol [2 weeks for each stage]

    Lipids

  5. Triglycerides [2 weeks for each stage]

    Lipids

  6. Glycosylated hemoglobin (HbA1C) [2 weeks for each stage]

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

Secondary Outcome Measures

  1. Blood pressure [2 weeks for each stage]

    physiological biomarkers

  2. Body composition [2 weeks for each stage]

    The percentages of fat, bone and muscle in human bodies by bioelectric impedance technology

  3. hs-CRP (high sensitivity C-reactive protein) [2 weeks for each stage]

    Inflammation

  4. Free T4 and TSH (Thyroid Stimulating Hormone) [2 weeks for each stage]

    Thyroid function tests

  5. Insulin [2 weeks for each stage]

    A peptide hormone produced by beta cells of the pancreatic islets

  6. Gastrin, Cholecystokinine, and Glucagon-like peptide 1 [2 weeks for each stage]

    Intestin Hormones

  7. Small-dense LDL-cholesterol [2 weeks for each stage]

    LDL subpopulation particles

Other Outcome Measures

  1. Pittsburgh Sleep Quality Index [2 weeks for each stage]

    Sleep quality assessment

  2. Center for Epidemiologic Studies Depression Scale (CES-D), NIMH [2 weeks for each stage]

    Depression scale assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 10002

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Ta-Chen Su, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05990595
Other Study ID Numbers:
  • 202206033RINC
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023