Peanut Consumption and Cardiovascular Disease Risk in a Chinese Population

NCT03194152 | Completed

• 1 other identifier: IRB17-0703
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T2D

Outcome Measures

Primary Outcomes (1)

• Blood glucose

  glucose, insulin, HbA1c

  Blood glucose will be measured at day 84.

Secondary Outcomes (5)

• Blood lipids level

  Blood lipids level will be measured at day 84.

• Blood Inflammatory status

  Inflammatory biomarkers will be measured at day 84.

• Assessment of appetite and other hunger sensations

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

• Microbiome

  Micriobiome will be measured at day 84.

• Polyphenol metabolites

  Polyphenol metabolites will be measured at day 84.

Study Arms (2)

Peanut

EXPERIMENTAL

Daily consumption of 2 servings of roasted peanuts for 12 weeks Intervention: Dietary Supplement: Roasted peanuts

Dietary Supplement: Peanut

Control

EXPERIMENTAL

Daily consumption of isocaloric matched snack food for 12 weeks Intervention: Other: High Carbohydrate Snack

Dietary Supplement: Control

Interventions

Peanut DIETARY_SUPPLEMENT

Dietary Supplement: Peanut

Peanut

Control DIETARY_SUPPLEMENT

Dietary Supplement: High carbohydrate snacks

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead

Study Sites (1)

Liang Sun

Shanghai, 200040, China

Location

Related Publications (1)

• 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.

  PMID: 33236043 DERIVED

Study Officials

• Xiaoran Liu, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Parallel design with two intervention arms

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 21, 2017
• Study Start: October 24, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

CN (1)