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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03194152
Other study ID # IRB17-0703
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2017
Est. completion date March 1, 2018

Study information

Verified date February 2019
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Emerging evidence has shown that peanut consumption has beneficial effects in modifying lipid profiles, glucose, and other cardiometabolic risk factors. During the last two decades, China has experienced a dramatic increase in T2D prevalence largely due to rapid social and economic growth. Peanuts are commonly consumed as snacks in China. However, there is limited evidence on the specific health benefits of peanuts as part of the Chinese habitual diet.

Clinical Study Protocol

Study diet Subjects will consume their habitual diet with the test snacks provided as roasted peanuts and rice flour snack bars twice a day during a mid- morning snack and mid -afternoon snack. Subjects in the peanut group will consume two serving of peanuts and subjects in the control group will consume isocaloric rice bars on a daily basis under on site supervision. Subjects will be instructed to maintain their habitual diet and physical activity. During the study period, body weight will be monitored routinely to ensure that baseline weight does not fluctuate by more than 1kg. Prior to day 1, day 42 and day 84, a three-day diet record will be administered to subjects to calculate basal energy intake.

Study design The study is a randomized, controlled, parallel-arm trial precedes by a 1-week run-in period with control treatment to assess compliance, acceptability and to determine baseline values.After the run-in period, participants will be randomized to either the control group or treatment group for three months. Each treatment phase will be 3 months in duration. At baseline, day 42 and day 84, clinical assessment (body weight, waist/hip circumference, blood pressure, pulse) will be preformed and blood samples will be collected. Urinary will be collected on baseline, day 42 and day 84. Fecal samples will be collected on baseline and day 84. Three days dietary records and appetite sensation ratings will be collected three times during the study (baseline, day 42 and day 84).


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Peanut
Dietary Supplement: Peanut
Control
Dietary Supplement: High carbohydrate snacks

Locations

Country Name City State
China Liang Sun Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Harvard School of Public Health

Country where clinical trial is conducted

China, 

Outcome

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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