Peanut Consumption and Cardiovascular Disease Risk in a Chinese Population

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

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.

Study Overview

• Status: Completed
• Conditions: T2D
• Intervention / Treatment: Dietary supplement: Peanut; Dietary supplement: Control

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200040
    • Liang Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peanut; Daily consumption of 2 servings of roasted peanuts for 12 weeks Intervention: Dietary Supplement: Roasted peanuts	Dietary supplement: Peanut; Dietary Supplement: Peanut
Experimental: Control; Daily consumption of isocaloric matched snack food for 12 weeks Intervention: Other: High Carbohydrate Snack	Dietary supplement: Control; Dietary Supplement: High carbohydrate snacks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose	glucose, insulin, HbA1c	Blood glucose will be measured at day 84.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipids level	cholesterol and triglyceride levels	Blood lipids level will be measured at day 84.
Blood Inflammatory status	Inflammatory biomarkers	Inflammatory biomarkers will be measured at day 84.
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.
Microbiome	fecal microbiome (subset) A subset of study subjects will be measured for fecal microbiome functionality.	Micriobiome will be measured at day 84.
Polyphenol metabolites	Urinary polyphenol metabolites (subset)	Polyphenol metabolites will be measured at day 84.

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Xiaoran Liu, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• Wang D, Sun L, Liu X, Niu Z, Chen S, Tang L, Zheng H, Chen X, Li H, Lu L, Malik V, Lin X. Replacing white rice bars with peanuts as snacks in the habitual diet improves metabolic syndrome risk among Chinese adults: a randomized controlled trial. Am J Clin Nutr. 2021 Jan 4;113(1):28-35. doi: 10.1093/ajcn/nqaa307.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB17-0703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No