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Completed

NCT Number: NCT03194152

Peanut Consumption and Cardiovascular Disease Risk in a Chinese Population

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.

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Key information

Conditions

T2D

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liang Sun

Shanghai, 200040, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Peanut

Dietary Supplement

Dietary Supplement: Peanut

Control

Dietary Supplement

Dietary Supplement: High carbohydrate snacks

Primary outcomes

  1. Blood glucose

    Time frame: Blood glucose will be measured at day 84.

    glucose, insulin, HbA1c

Secondary outcomes

  1. Blood lipids level

    Time frame: Blood lipids level will be measured at day 84.

    cholesterol and triglyceride levels

  2. Blood Inflammatory status

    Time frame: Inflammatory biomarkers will be measured at day 84.

    Inflammatory biomarkers

  3. Assessment of appetite and other hunger sensations

    Time frame: Appetite and other hunger sensations will be measured at day 84.

    Appetite and other hunger sensations will be assessed using visual analogue scales

  4. Microbiome

    Time frame: Micriobiome will be measured at day 84.

    fecal microbiome (subset) A subset of study subjects will be measured for fecal microbiome functionality.

  5. Polyphenol metabolites

    Time frame: Polyphenol metabolites will be measured at day 84.

    Urinary polyphenol metabolites (subset)

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Registry information

Official study title

Effects of Peanut Consumption on Cardiovascular Disease Risk Factors and Gut Microbiota Among Adults in China: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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