Trial Outcomes & Findings for Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile (NCT NCT02391701)

Results Overview

Change from baseline in total cholesterol: Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics) \[Time Frame: 6 months \]

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

720 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2020-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Diet Group Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control No intervention
Overall Study STARTED	367	353
Overall Study COMPLETED	346	315
Overall Study NOT COMPLETED	21	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diet Group n=367 Participants Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control n=353 Participants No intervention	Total n=720 Participants Total of all reporting groups
Age, Categorical <=18 years	80 Participants n=5 Participants	66 Participants n=7 Participants	146 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	238 Participants n=5 Participants	255 Participants n=7 Participants	493 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	32 Participants n=7 Participants	81 Participants n=5 Participants
Age, Continuous	38.6 years STANDARD_DEVIATION 19.8 • n=5 Participants	40.2 years STANDARD_DEVIATION 20.8 • n=7 Participants	39.4 years STANDARD_DEVIATION 20.3 • n=5 Participants
Sex: Female, Male Female	214 Participants n=5 Participants	211 Participants n=7 Participants	425 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants	142 Participants n=7 Participants	295 Participants n=5 Participants
Region of Enrollment Spain	367 participants n=5 Participants	353 participants n=7 Participants	720 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

Change from baseline in total cholesterol: Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics) \[Time Frame: 6 months \]

Outcome measures

Outcome measures
Measure	Diet Group n=367 Participants Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control n=353 Participants No intervention
Changes in Total-cholesterol Levels	-6.9 mg/dl Interval -9.3 to -4.5	-0.6 mg/dl Interval -3.1 to 2.0

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

Measurements will be made in triplicate and recorded by standard methods using a SECA 813 digital balance with the subjects in underwear and barefoot. Body weight will be measured to the nearest 0.1 kg.

Outcome measures

Outcome measures
Measure	Diet Group n=367 Participants Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control n=353 Participants No intervention
Change From Baseline in Body Weight	-0.32 Kg Interval -0.62 to -0.01	0.62 Kg Interval 0.33 to 0.91

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intent to treat population (all adult participants who were randomized). The BMI of subjects under 18 years of age were not included (80 participants in the Diet Group and 66 participants in the Control Group).

BMI will be calculated as body weight (kg) divided by height (m) squared. The BMI of subjects under 18 years of age will be standardised using World Health Organization (WHO) reference data.

Outcome measures

Outcome measures
Measure	Diet Group n=287 Participants Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control n=287 Participants No intervention
Change From Baseline in Body Mass Index (BMI)	-0.29 Kg/m2 Interval -0.43 to -0.16	0.17 Kg/m2 Interval 0.04 to 0.29

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

Waist circumference will be measured at the narrowest point between the bottom rib and the top of the iliac crest using a SECA 201 flexible, non-elastic tape. Hip circumference will be measured at the point of greatest prominence of the gluteal muscles using a SECA 201 flexible, non-elastic tape.

Outcome measures

Outcome measures
Measure	Diet Group n=367 Participants Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control n=353 Participants No intervention
Change From Baseline in Hip/Waist Index	-0.015 Ratio Interval -0.02 to -0.01	-0.003 Ratio Interval -0.008 to 0.001

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

Outcome measures

Outcome measures
Measure	Diet Group n=367 Participants Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine. Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)	Control n=353 Participants No intervention
Change From Baseline in Fasting Plasma Glucose	-1.9 mg/dL Interval -2.9 to -0.9	-2.6 mg/dL Interval -3.6 to -1.6

Adverse Events

Diet Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. María del Mar Calvo Malvar

Hospital Clínico Universitario de Santiago

Phone: 34 981950395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place