T2D Clinical Trial
Official title:
Effects of Peanut Consumption on Cardiovascular Disease Risk Factors and Gut Microbiota Among Adults in China: A Randomized Controlled Trial
Verified date | February 2019 |
Source | Harvard School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 2 parallel-arm randomized controlled study with free-living subjects on
self-selected diets. The objective of this study is to compare the effects of two servings of
peanuts with an isocaloric matched refined carbohydrate snack food on glucose, lipids and
lipoproteins and cardiovascular health risk factors, satiety and gut microbiota in 250
Chinese participants at risk for metabolic syndrome (overweight/obese, enlarged waist
circumference, elevated LDL-cholesterol, prehypertension, and/or prediabetes).
The investigators hypothesize that the inclusion of 2 serving of peanuts in the diet will
decrease blood glucose, LDL-cholesterol, and improve satiety sanctification between meals and
gut microbiota compared to the control group and baseline.
Status | Completed |
Enrollment | 238 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 20-65 - Increased waist circumference : = 90 cm for men and = 80 cm for women Plus 1 or more of the remaining criteria: - Elevated TG level = 1.7 mmo/L - Reduced HDL-Cholesterol < 1.03 mmol/L in men and < 1.29 mmol/L in women) - Fasting glucose = 5.6 mmol/L - Systolic/diastolic blood pressure = 130/85 mmHg. Exclusion Criteria: - Taking lipid lowering medications - With known or unknown peanut allergy (or any peanut containing products) - Thyroid disease - Diabetes mellitus - Kidney disease - Liver disease - Cardiovascular disease or cancer - Pregnant or lactating women - Heavy alcohol consumption (>14 drinks/week) |
Country | Name | City | State |
---|---|---|---|
China | Liang Sun | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose | glucose, insulin, HbA1c | Blood glucose will be measured at day 84. | |
Secondary | Blood lipids level | cholesterol and triglyceride levels | Blood lipids level will be measured at day 84. | |
Secondary | Blood Inflammatory status | Inflammatory biomarkers | Inflammatory biomarkers will be measured at day 84. | |
Secondary | Assessment of appetite and other hunger sensations | Appetite and other hunger sensations will be assessed using visual analogue scales | Appetite and other hunger sensations will be measured at day 84. | |
Secondary | Microbiome | fecal microbiome (subset) A subset of study subjects will be measured for fecal microbiome functionality. | Micriobiome will be measured at day 84. | |
Secondary | Polyphenol metabolites | Urinary polyphenol metabolites (subset) | Polyphenol metabolites will be measured at day 84. |
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