Obesity, diabetes, cardiovascular disease
Conditions
Interventions
Obesity population:Participants in the control group maintained their current diet and participants in the intervention group were given 50g/d and 100g/d of whole grains, respectively
People at risk for diabetes:Participants in the control group maintained their current diet and participants in the intervention group were given 50g/d and 100g/d of whole grains, respectively
People at risk for cardiovascular disease:Participants in the control group maintained their current diet and participants in the intervention group were given 50g/d and 100g/d of whole grains, respec
Sponsors
National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Part 1: Obesity population 1. Aged 18-65 years old. 2. Obese 28 = BMI <40. 3.Voluntary participation in this trial and signed informed consent form. Part 2: People at risk for diabetes 1. Aged 18-65 years old 2.Referring to the 2023 edition of the American Diabetes Association Diabetes Diagnostic Criteria, at least 1 or more conditions were met as the main criteria for enrollment, namely: fasting blood glucose 5.6-6.9 mmol/L, glycated hemoglobin 5.7-6.4%, and blood glucose 7.8-11.0 mmol/L two hours after the 75g anhydrous glucose OGTT test. 3.Voluntary participation in this trial and signed informed consent form. Part 3: People at risk for cardiovascular disease 1. Aged 18-65 years old. 2.Referring to the marginal elevation and elevation of the reference standard for major lipid indicators in the Chinese population of the Chinese Guidelines for Lipid Management (2023), meeting at least 1 or more conditions was used as the main criterion for enrollment, namely: total cholesterol TC: TC =5.2 mmol/L, triglycerides TG: TG =1.7 mmol/L, low-density lipoprotein cholesterol LDL-C: LDL-C =3.4 mmol/L, HDL-C: HDL-C <1.0 mmol/L. 3.Voluntary participation in this trial and signed informed consent form.
Exclusion criteria
Exclusion criteria: Part 1: Obesity population 1.Patients with gastrointestinal disorders, tumors, diabetes, cardiovascular diseases, cardiac, hepatic and renal insufficiency, serious infectious diseases, autoimmune diseases 2.People taking blood pressure-lowering drugs, glucose-lowering drugs, lipid-lowering drugs, people who are pregnant and preparing for pregnancy, and people who have been taking nutrient supplements containing multivitamins, fish oil, n-3 fatty acids, etc. continuously for one month 3.People with allergies to whole grains and those who consume more than 50g/d of whole grains per day 4.People who have changed their weight by more than 3% in the last three months or who are taking any medication that may affect their weight. 5.Those who, in the judgment of the investigator, are unable to complete the study for any other reason Part 2: Diabetes population Exclusion criteria: 1.Patients with gastrointestinal disorders, tumors, diabetes, cardiovascular diseases, cardiac, hepatic and renal insufficiency, serious infectious diseases, and autoimmune diseases; 2.Patients taking blood pressure, blood sugar and lipid-lowering drugs, people during pregnancy and pregnancy preparation, and people who have been taking multivitamins, fish oil, n-3 fatty acids and other nutrient supplements within one month; 3.Patients with allergies to whole grains and those who consume more than 50g/d of whole grains per day; 4.Those who, in the judgment of the investigator, are unable to complete the study for any other reason Part 3: Cardiovascular disease population Exclusion criteria: 1.Patients with gastrointestinal disorders, tumors, diabetes, cardiovascular diseases, cardiac, liver and kidney insufficiency, serious infectious diseases, and autoimmune diseases; 2.Patients taking blood pressure, blood sugar and lipid-lowering drugs, people during pregnancy and pregnancy preparation, and people who have been taking multivitamins, fish oil, n-3 fatty acids and other nutrient supplements within one month; 3. People with allergies to whole grains and those consuming more than 50 g/d of whole grains per day; 4.Those who, in the judgment of the investigator, are unable to complete the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI, Body Mass Index;Body composition;Waist circumference;cardiovascular risk factors (Blood pressure, lipids, glucose);Immunological indicators;Intestinal flora and its metabolites;Blood Metabolites; | — |
Countries
China
Contacts
Public ContactZhaolong Gong
National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention
Outcome results
None listed