T2DNCT03194152
Peanut Consumption and Cardiovascular Disease Risk in a Chinese Population
A study testing Peanut in people with T2D, run by Harvard School of Public Health (HSPH) at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- T2D
- What is being tested?
- Peanut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Taking lipid lowering medications
- With known or unknown peanut allergy (or any peanut containing products)
- Thyroid disease
- Diabetes mellitus
- Kidney disease
- Liver disease
Show all 9Show fewer
- Cardiovascular disease or cancer
- Pregnant or lactating women
- Heavy alcohol consumption (>14 drinks/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- T2D
- Being tested
- Peanut, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeanutDietary supplement
Dietary Supplement: Peanut
ControlDietary supplement
Dietary Supplement: High carbohydrate snacks
| Study group | Role | What they receive |
|---|---|---|
| Peanut | Experimental | Daily consumption of 2 servings of roasted peanuts for 12 weeks Intervention: Dietary Supplement: Roasted peanuts Receives: Dietary Supplement: Peanut |
| Control | Experimental | Daily consumption of isocaloric matched snack food for 12 weeks Intervention: Other: High Carbohydrate Snack Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
glucose, insulin, HbA1c
Measured: Blood glucose will be measured at day 84.
Secondary outcomes (5)
Blood lipids level
cholesterol and triglyceride levels
Measured: Blood lipids level will be measured at day 84.
Blood Inflammatory status
Inflammatory biomarkers
Measured: 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
Measured: 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.
Measured: Micriobiome will be measured at day 84.
Polyphenol metabolites
Urinary polyphenol metabolites (subset)
Measured: Polyphenol metabolites will be measured at day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start24 Oct 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel design with two intervention arms
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasanti Malik, Harvard School of Public Health (HSPH)
- Investigators
- Xiaoran Liu, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194152
- Sponsor's protocol ID
- IRB17-0703
- Status last verified
- Feb 2019
- First submitted
- 5 Jun 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33236043
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peanut Consumption on Cardiovascular Disease Risk Factors and Gut Microbiota Among Adults in China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03194152
- Acronym / sponsor ID
- IRB17-0703
- Conditions
- T2D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel design with two intervention arms
| Arm | Type | Receives |
|---|---|---|
| Peanut | Experimental | Dietary Supplement: PeanutDaily consumption of 2 servings of roasted peanuts for 12 weeks Intervention: Dietary Supplement: Roasted peanuts |
| Control | Experimental | Dietary Supplement: ControlDaily consumption of isocaloric matched snack food for 12 weeks Intervention: Other: High Carbohydrate Snack |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 20-65
- Increased waist circumference : ≥ 90 cm for men and ≥ 80 cm for women
- 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
Key exclusion criteria (9 listed)
- Taking lipid lowering medications
- With known or unknown peanut allergy (or any peanut containing products)
- Thyroid disease
- Diabetes mellitus
- Kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeanutDietary Supplement: Peanut | Dietary supplement | Peanut |
| ControlDietary Supplement: High carbohydrate snacks | Dietary supplement | Control |
Primary outcome
Blood glucose
Time frame: Blood glucose will be measured at day 84.
glucose, insulin, HbA1c
5 secondary outcomes
Blood lipids level
Time frame: Blood lipids level will be measured at day 84.
Blood Inflammatory status
Time frame: Inflammatory biomarkers will be measured at day 84.
Assessment of appetite and other hunger sensations
Time frame: Appetite and other hunger sensations will be measured at day 84.
Microbiome
Time frame: Micriobiome will be measured at day 84.
Polyphenol metabolites
Time frame: Polyphenol metabolites will be measured at day 84.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 33236043Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoran Liu, PhD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut in people with T2D, run by Harvard School of Public Health (HSPH) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Blood glucose will be measured at day 84.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.