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Changes in Acid Base Status During High Salt Intake (SL8)

G

German Aerospace Center (DLR)

Status

Completed

Conditions

Low Grade Metabolic Acidosis

Treatments

Dietary Supplement: High NaCl + KHCO3
Other: Control: high NaCl

Study type

Interventional

Funder types

Other

Identifiers

NCT01655953
DLR Salty Life 8 Study

Details and patient eligibility

About

The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride, salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced physiological systems. Due to increased urinary calcium excretion and bone resorption a high NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet is known to have a beneficial influence on bone metabolism. Therefore the investigators hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.

8 healthy male volunteers took part in a stationary study carried out in the metabolic ward of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days. Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7 mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate (KHCO3) in a randomized cross-over design. The other campaign served as control.

Bone metabolism was studied by bone formation markers in the fasting morning blood and 24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in the fasted and the postprandial state as well as urinary markers. Protein turnover was studied with stable isotopes. Further physiological systems like energy metabolism and the cardiovascular system are also under investigation.

Enrollment

8 patients

Sex

Male

Ages

19 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy males
  • 19 - 35 years
  • 65 - 85kg
  • 170 - 190 cm
  • successfully completed psychological and medical screening

Exclusion criteria

  • athletes
  • smoking
  • drug- or alcohol abuse
  • hyperlipidemia
  • renal diseases
  • obesity
  • anemia
  • bone diseases
  • diabetes
  • rheumatism
  • blood donation within three month prior to study start
  • participation in another clinical investigation three month prior to study start

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

8 participants in 2 patient groups

Campaign 1
Experimental group
Treatment:
Dietary Supplement: High NaCl + KHCO3
Other: Control: high NaCl
Campaign 2
Experimental group
Treatment:
Dietary Supplement: High NaCl + KHCO3
Other: Control: high NaCl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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