Diet TherapyNCT03341650
High Pasta vs. Low Pasta Diet in the Treatment of Obesity
A study testing High Pasta and Low Pasta in people with Diet Therapy, run by University of Parma at 1 site in Italy.
Trial summary
To the best of our knowledge, the effect of pasta consumption within a hypocaloric Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group dietary intervention was carried out to investigate if pasta consumption could affect the BMI change in obese patients. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Therapy
- What is being tested?
- High Pasta and Low Pasta
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2015to Dec 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 30-45 kg/m2
- healthy subjects
- regular meal consumption
- no celiac disease
- no menopause woman
Who cannot join
- with a BMI <30 or >45 kg/m2
- having diabetes, hepatic or kidney diseases
- having an eating disorder
- having celiac disease
- menopause woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients
To the best of our knowledge, the effect of pasta consumption within a hypocaloric Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group dietary intervention was carried out to investigate if pasta consumption could affect the BMI change in obese patients. The primary outcome was the loss of at leat 8% of the initial body weight in the first 6 months. Anthropometric and body composition (from bioelectrical impedance analysis - BIA-) measures were collected every month for the first 6 months and after 1 year. In addition, dietary information was collected at baseline and after 3, 6 and 12 months through a 7-day carbohydrate food record and a 24-h food recall. Blood samples were collected at baseline and at 6 and 12 months to assess: glucose, insulin, Homeostatic model assessment for insulin resistant (HOMA-IR) index, total cholesterol, low-density lipoprotein, high-density lipoprotein, and uric acid. Furthermore, the perceived quality of life was investigated through the 36-items short form health survey (SF36) questionnaire.
- Conditions
- Diet Therapy
- Being tested
- High Pasta, Low Pasta
- Keywords
- Mediterranean Diet, BMI, weight loss, pasta, obesity
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High PastaBehavioural
Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (at least 5 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
Low PastaBehavioural
Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (no more than 3 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
| Study group | Role | What they receive |
|---|---|---|
| High Pasta | Experimental | Habitual pasta consumption equal or higher than 5 times/week. Receives: Behavioral: High Pasta |
| Low Pasta | Experimental | Habitual pasta consumption equal or lower than 3 times/week. Receives: Behavioral: Low Pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Body weight at 6 months
Measured in kg according to the standard procedure
Measured: baseline, 6 months
Secondary outcomes (19)
Change from baseline Body weight at 3 months
Measured in kg according to the standard procedure
Measured: baseline, 3 months
Change from baseline Body weight at 12 months
Measured in kg according to the standard procedure
Measured: baseline, 12 months
BMI
Calculated as body weight in kilograms divided by the square of the height in meters
Measured: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Waist circumference
Measured in cm according to the standard procedure
Measured: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Free Fat Mass
Estimated by bioelectrical impedance analysis in kg and in %
Measured: baseline, 3 months, 6 months, 12 months
Fat Mass
Estimated by bioelectrical impedance analysis in kg and in %
Measured: baseline, 3 months, 6 months, 12 months
Basal Metabolic Rate
Estimated by bioelectrical impedance analysis in kcal/day
Measured: baseline, 3 months, 6 months, 12 months
Glucose
mg/dL in fasting condition
Measured: baseline, 6 months, 12 months
Insulin
microU/mL in fasting condition
Measured: baseline, 6 months, 12 months
HOMA-IR index
calculated from glucose and insulin in fasting condition
Measured: baseline, 6 months, 12 months
Total cholesterol
mg/dL in fasting condition
Measured: baseline, 6 months, 12 months
HDL cholesterol
mg/dL in fasting condition
Measured: baseline, 6 months, 12 months
LDL cholesterol
mg/dL in fasting condition
Measured: baseline, 6 months, 12 months
Triglycerides
mg/dL in fasting condition
Measured: baseline, 6 months, 12 months
Uric Acid
mg/dL in fasting condition
Measured: baseline, 6 months, 12 months
Energy intake
assessed by a 24-h dietary recall as kcal/day
Measured: baseline, 3 months, 6 months, 12 months
Nutrient intakes
assessed by a 24-h dietary recall as g/day
Measured: baseline, 3 months, 6 months, 12 months
Carbohydrate-based food intakes
assessed by a 7-day food diary as times/week
Measured: baseline, 3 months, 6 months, 12 months
Perceived Quality of Life
assessed by the SF36 questionnaire
Measured: baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start2 Nov 2015
- Primary completionDec 2017
- Study completionDec 2017
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 Diet TherapyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Scazzina Ph.D., University of Parma
- Investigators
- Elisabetta Dall'Aglio, MD, Study director, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341650
- Sponsor's protocol ID
- SP2
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rosi A, Tesan M, Cremonini A, Biasini B, Bicchieri L, Cossu M, Brighenti F, Dall'Aglio E, Scazzina F. Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention. Nutr Metab Cardiovasc Dis. 2020 Jun 9;30(6):984-995. doi: 10.1016/j.numecd.2020.02.013. Epub 2020 Feb 24.
PubMed 32402585
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients
- ClinicalTrials.gov ID
- NCT03341650
- Acronym / sponsor ID
- SP2
- Conditions
- Diet Therapy
- Keywords
- Mediterranean Diet, BMI, weight loss, pasta, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Nov 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.
To the best of our knowledge, the effect of pasta consumption within a hypocaloric Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group dietary intervention was carried out to investigate if pasta consumption could affect the BMI change in obese patients. The primary outcome was the loss of at leat 8% of the initial body weight in the first 6 months. Anthropometric and body composition (from bioelectrical impedance analysis - BIA-) measures were collected every month for the first 6 months and after 1 year. In addition, dietary information was collected at baseline and after 3, 6 and 12 months through a 7-day carbohydrate food record and a 24-h food recall. Blood samples were collected at baseline and at 6 and 12 months to assess: glucose, insulin, Homeostatic model assessment for insulin resistant (HOMA-IR) index, total cholesterol, low-density lipoprotein, high-density lipoprotein, and uric acid. Furthermore, the perceived quality of life was investigated through the 36-items short form health survey (SF36) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Pasta | Experimental | Behavioral: High PastaHabitual pasta consumption equal or higher than 5 times/week. |
| Low Pasta | Experimental | Behavioral: Low PastaHabitual pasta consumption equal or lower than 3 times/week. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 30-45 kg/m2
- healthy subjects
- regular meal consumption
- no celiac disease
- no menopause woman
Key exclusion criteria (5 listed)
- with a BMI <30 or >45 kg/m2
- having diabetes, hepatic or kidney diseases
- having an eating disorder
- having celiac disease
- menopause woman
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 |
|---|---|---|
| High PastaParticipants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (at least 5 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations. | Behavioural | High Pasta |
| Low PastaParticipants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (no more than 3 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations. | Behavioural | Low Pasta |
Primary outcome
Change from baseline Body weight at 6 months
Time frame: baseline, 6 months
Measured in kg according to the standard procedure
19 secondary outcomes
Change from baseline Body weight at 3 months
Time frame: baseline, 3 months
Change from baseline Body weight at 12 months
Time frame: baseline, 12 months
BMI
Time frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Waist circumference
Time frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Free Fat Mass
Time frame: baseline, 3 months, 6 months, 12 months
Fat Mass
Time frame: baseline, 3 months, 6 months, 12 months
Basal Metabolic Rate
Time frame: baseline, 3 months, 6 months, 12 months
Glucose
Time frame: baseline, 6 months, 12 months
Insulin
Time frame: baseline, 6 months, 12 months
HOMA-IR index
Time frame: baseline, 6 months, 12 months
Total cholesterol
Time frame: baseline, 6 months, 12 months
HDL cholesterol
Time frame: baseline, 6 months, 12 months
LDL cholesterol
Time frame: baseline, 6 months, 12 months
Triglycerides
Time frame: baseline, 6 months, 12 months
Uric Acid
Time frame: baseline, 6 months, 12 months
Energy intake
Time frame: baseline, 3 months, 6 months, 12 months
Nutrient intakes
Time frame: baseline, 3 months, 6 months, 12 months
Carbohydrate-based food intakes
Time frame: baseline, 3 months, 6 months, 12 months
Perceived Quality of Life
Time frame: baseline, 3 months, 6 months, 12 months
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 4 May 2018.
- Derived from this study: PubMed 32402585Rosi A, Tesan M, Cremonini A, Biasini B, Bicchieri L, Cossu M, Brighenti F, Dall'Aglio E, Scazzina F. Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention. Nutr Metab Cardiovasc Dis. 2020 Jun 9;30(6):984-995. doi: 10.1016/j.numecd.2020.02.013. Epub 2020 Feb 24.
- Individual participant dataSharing planned: Undecided
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Healthy Volunteers
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.
Elisabetta Dall'Aglio, MD study director
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Pasta and Low Pasta in people with Diet Therapy, run by University of Parma at 1 site in Italy.
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 5 inclusion and 5 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 4 May 2018. 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 Italy. 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?
Change from baseline Body weight at 6 months (time frame: baseline, 6 months). 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 NCT03341650, 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 4 May 2018.